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Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients

Study Purpose

Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal. In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development. Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation. Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

  • - Histologically and/or cytologically documented (documentation obtained before or after diagnostic surgical procedure when clinical suspicion is strong), cancers for the following cohorts: o Breast carcinomas.
o Gastric carcinomas. o Renal carcinomas. o Prostate carcinomas. o Lung carcinomas: NSCLC and SCLC. o Hepatocellular carcinomas. o Colorectal carcinomas.
  • - Head and neck carcinomas.
  • - Thyroid cancer.
  • - Pancreatic carcinomas.
  • - Ovarian adenocarcinomas.
  • - Glioblastoma.
  • - Endometrial adenocarcinomas.
  • - Bladder carcinoma.
  • - Superficial Oesophago-gastric carcinomas.
  • - Diffuse Large B-cell Lymphomas.
  • - Patient older than 18 years.
  • - Patients who gave its written informed consent to participate to the study.
  • - Patients affiliated to a social insurance regime.
Specific inclusion criteria for curative treatment strategy cancer patients:
  • - Indication of a treatment strategy with curative intent (surgery; radiotherapy; chemotherapy; hormonotherapy; targeted agents…) - Patient naïve of anticancer treatments for the considered cancer.
  • - A prior anti-cancer treatment is allowed if this treatment was performed with curative intent, and if it did not include systemic chemotherapy, and if a complete remission ≥ 6 months was observed in between the end of treatment and relapse.
Previous local treatments for superficial lesions are allowed without any time restriction (for example among others, intravesical treatment for superficial bladder cancer lesions). Specific inclusion criteria for non-curative treatment strategy cancer patients:
  • - Indication of a treatment strategy with no curative intent (radiotherapy; chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery, …) - Patient naïve of anticancer treatments in non-curative setting (except for metastatic hormone-sensitive prostate cancer, see specific inclusion criteria).
The following tumor type specific inclusion criteria must be met in addition to the inclusion criteria listed above: Breast carcinomas. • All cohorts:
  • - Invasive breast ductal carcinoma, or.
  • - Invasive breast lobular carcinoma.
  • - Curative intent treatment patient cohort: - Planned to be treated with surgery, with/without neo-adjuvant and/or adjuvant chemotherapy and/or anti-hormone treatment.
Gastric carcinomas.
  • - All cohorts: o Intestinal-type adenocarcinoma, or.
o Diffuse cell type adenocarcinoma.
  • - Curative intent treatment patient cohort: - Planned to be treated with surgery with/without neo-adjuvant treatment, with/without adjuvant treatment.
Renal carcinomas • All cohorts:
  • - Any histology of renal cancer is accepted (non-clear cell renal cancer could be included) - A pathology proof of renal cell carcinoma is not necessarily provided if patients present typical radiologic characteristics of renal cancer on imaging.
• Curative intent treatment patients cohort:
  • - Planned to be treated with partial or total nephrectomy.
Prostate carcinomas.
  • - Curative intent treatment patients cohort: o Localized prostate cancer with high risk features : StageT2b , T2c or T3 and/or Gleason >= 4+3 and/or PSA >= 20 and/or N+ o Planned to be treated with radical prostatectomy or radiotherapy (potentially associated with androgen deprivation therapy).
Brachytherapy and/or focused ultrasounds are not allowed.
  • - Non-curative intent treatment patients cohort: - Patients with metastatic castration resistant prostate cancer (mCRPC) defined by validated criteria of EAU, planned to be treated with doceteaxel or cabazitaxel or second generation hormone (i.e. abiraterone or enzalutamide).
Patients have to be naïve of treatment for the castration resistant mCRPC. Patients that previously received docetaxel or a 1st or 2nd generation hormonotherapy for their hormone-sensitive prostate cancer in metastatic setting can be included. Lung carcinomas treated by immunotherapy : • Non-curative intent patients cohort: o NSCLC stage IV according to 8th TNM classification planned to be treated with immunotherapy, with/ without chemotherapy. Lung carcinomas excluding those treated with immunotherapy:
  • - Curative intent treatment patients cohort: o NSCLC histology only.
o Stage I-II according to 8th TNM classification. o Stage IIIA-B according to 8th TNM classification. o Planned to be treated with radical treatment (surgery or radiotherapy with/without concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant treatment.
  • - Non-curative intent patients cohort: - NSCLC or SCLC stage IV according to 8th TNM classification planned to be treated with a first line of chemotherapy, with/without associated treatments except immunotherapy (radiotherapy, targeted therapies…).
Immunotherapy can be administrated for the subsequent lines of treatment. Hepatocellular carcinomas A pathology proof of HCC is not necessarily provided if patients present typical radiologic characteristics of hepatocellular carcinoma on imaging.
  • - Absence or chronic hepatic encephalopathy, absence of refractory ascites.
  • - Curative intent treatment patients cohort: - Indication of a treatment strategy with curative intent, except liver transplantation: surgical resection, monopolar radiofrequency ablation for HCC (1 to 3 nodules ≤3 cm) or multibipolar radiofrequency if nodule ≤4 cm).
• Non-curative intent patients cohort:
  • - Indication of a treatment strategy with no curative intent: transarterial intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or monoclonal antibodies) or immune therapy.
Colorectal carcinomas. • Curative intent treatment patients cohort: o Lieberkühn adenocarcinoma associated with metastases planned to be treated with peri-operative chemotherapy +/- targeted agent and interval surgery. Head and neck carcinomas.
  • - All cohorts.
o Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx, larynx.
  • - Curative intent treatment patients cohort: o Planned to be treated with a radical treatment (surgery and/or radiotherapy potentially associated with concurrent chemotherapy) with/without neo-adjuvant/adjuvant chemotherapy.
  • - Non-curative intent treatment patients cohort: o De novo metastatic or metastatic/loco-regional relapse planned to be treated with chemotherapy and/or immunotherapy.
Thyroid cancer • Curative intent patient cohort o Thyroid carcinoma differentiated, poorly differentiated, papillary, vesicular, Hurthle Cell o For which a iodine treatment is indicated (Iodine treatment will be discussed after surgery. In the case the histological result does not confirm a high risk thyroid cancer, patient will be withdrawn from the study. In the same way, if a iodine treatment is not recommended after surgery, patient will be withdrawn from the study. In both cases, patient will be replaced). Pancreatic carcinomas. • Curative intent patients cohort: o Pancreas exocrine adenocarcinoma planned to be treated with initial surgery with/without neo-adjuvant chemotherapy and with/without adjuvant chemotherapy or radiotherapy. Ovarian adenocarcinomas • Non/uncertain curative intent patients cohort: o 1st platinum-sensitive relapse.
  • - High or low grade epithelial adenocarcinomas or carcinosarcoma.
  • - Planned to be treated with chemotherapy and/or PARP inhibitors based treatment, +/- interval debulking surgery.
Glioblastoma • Curative intent patients cohort: o Planned to be treated with surgical resection, followed by adjuvant temozolomide and radiotherapy. Endometrial adenocarcinomas.
  • - Non-curative intent patients cohort: o Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell, undifferentiated carcinoma and carcinosarcoma) cancers.
o Planned to be treated with non-curative systemic treatment for metastatic or advanced disease. Bladder carcinoma.
  • - Transitional cell carcinoma • Curative intent treatment patients: - Patients with localized muscle invasive bladder cancer (>=PT2) - Planned to be treated with neo-adjuvant cisplatin based chemotherapy, or immunotherapy or a combination of chemotherapy and immunotherapy.
Superficial Oesophago-gastric cancer • Curative intent patients cohort: o Superficial oesophago-gastric carcinomas (adenocarcinomas or epidermoid carcinomas) of Stage T1 planned to be treated by endoscopic surgery. Diffuse Large B-Cell Lymphoma (DLBCL) • Curative intent patients cohort: o Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin, Prednisone)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03787056
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospices Civils de Lyon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Benoit YOU, MD
Principal Investigator Affiliation Hospices Civils de Lyon
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer, Breast Cancer, Gastric Cancer, Renal Cancer, Prostate Cancer, Melanoma, Lung Cancer, Hepatocellular Cancer, Colorectal Cancer, Head and Neck Cancer, Pancreatic Cancer, Ovarian Cancer, Glioblastoma, Endometrial Cancer, Bladder Cancer, Esophageal Cancer, B-cell Lymphoma
Arms & Interventions

Arms

Other: Cancer patients

420 patients affected by different types of cancer and treated in a curative or a palliative intent. In total 17 cohorts will be open, including: breast cancer, head and neck carcinomas, renal cell carcinoma, prostate carcinoma, lung carcinoma, hepatocellular carcinoma, colorectal carcinoma, thyroid cancer, pancreatic adenocarcinoma, ovarian adenocarcinoma, glioblastoma, endometrial adenocarcinoma, bladder carcinoma, oesophago-gastric carcinoma, B-cell lymphoma, gastric carcinomas. Patients enrolled in curative intent treatment cohorts will never have been previously treated for their cancer. Patients enrolled in non-curative intent treatment cohorts will have never been treated for their metastatic cancers previously, or have developed advanced/metastatic diseases as relapses of localized cancers previously treated with curative intent therapeutic strategies. Other cohort will be open (stability cohorts) : nychtemer cohort and post-operative kinetic cohort.

Interventions

Other: - Blood draws

Blood draws are realized at each steps of patient disease management. The volume of each blood drawn is 25 mL for progastrin measurements and 5 mL for the dosage of the other tumor markers. The frequency depend to the cancer and treatment administered : Baseline at diagnosis : Local radical treatment : within 24h before surgery, within 24h after surgery and at the post-surgery follow up visit Chemotherapy treatment : every 3 or 4 weeks Radiotherapy : start day and at the end of radiation ("end of treatment" visit) Palliative systemic treatment (only palliative cohorts) : every 3 to 12 weeks. Follow until the third progression or change of treatment line, or alternatively up to 5 years after inclusion In case of PD or TOX Follow up: at each visit scheduled (every 3 months) for the first 2 years, then every 6 months for 3 years Relapse : withdrawn from the study and last progastrin measurement. Patient could be enrolled in the non-curative intent cohort

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bron, France

Status

Recruiting

Address

Service de NEURO-ONCOLOGIE du Groupement Hospitalier EST

Bron, ,

Site Contact

Francois DUCRAY, MD

[email protected]

04 78 86 43 53

Lyon, France

Status

Recruiting

Address

Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'hôpital de la Croix-Rousse

Lyon, ,

Site Contact

Marielle GUILLET, MD

[email protected]

04 78 86 43 53

Lyon, France

Status

Recruiting

Address

Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'Hôpital E. Herriot

Lyon, ,

Site Contact

Thomas WALTER, MD

[email protected]

04 78 86 43 53

Lyon, France

Status

Recruiting

Address

Service d'Oto-Rhino-Laryngologie de l'Hôpital de la Croix-Rousse

Lyon, ,

Site Contact

Amandine BRUYAS, MD

[email protected]

04 78 86 43 53

Lyon, France

Status

Recruiting

Address

Service d'Urologie de l'Hôpital E. Herriot

Lyon, ,

Site Contact

Lionel BADET, MD

[email protected]

04 78 86 43 53

Lyon, France

Status

Recruiting

Address

Service de Gynécologie de l'hôpital de la Croix-Rousse

Lyon, ,

Site Contact

Marion CORTET, MD

[email protected]

04 78 86 43 53

Lyon, France

Status

Recruiting

Address

Service de Gynécologie du Groupement Hospitalier Est

Lyon, ,

Site Contact

Christophe SAJOUS, MD

[email protected]

04 78 86 43 53

Lyon, France

Status

Recruiting

Address

Service de Pneumologie de l'hôpital de la Croix-Rousse

Lyon, ,

Site Contact

Gilles DEVOUASSOUX, MD

[email protected]

04 78 86 43 53

Lyon, France

Status

Recruiting

Address

Service de Pneumologie du Groupement Hospitalier Est

Lyon, ,

Site Contact

Michael DURUISSEAUX, MD

[email protected]

04 78 86 43 53

Pierre-Bénite, France

Status

Recruiting

Address

Service d'Hématologie de l'Hôpital Lyon Sud

Pierre-Bénite, ,

Site Contact

Lionel KARLIN, MD

[email protected]

04 78 86 43 53

Pierre-Bénite, France

Status

Recruiting

Address

Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE du Centre Hospitalier Lyon Sud

Pierre-Bénite, ,

Site Contact

Marion CHAUVENET, MD

[email protected]

04 78 86 43 53

Pierre-Bénite, France

Status

Recruiting

Address

Service d'Oncologie médicale du Centre hospitalier Lyon Sud

Pierre-Bénite, ,

Site Contact

Benoit YOU, MD

[email protected]

04 78 86 43 53

Service d'Urologie de l'hôpital Lyon Sud, Pierre-Bénite, France

Status

Recruiting

Address

Service d'Urologie de l'hôpital Lyon Sud

Pierre-Bénite, ,

Site Contact

Philippe PAPAREL, MD

[email protected]

04 78 86 43 53

Pierre-Bénite, France

Status

Recruiting

Address

Service de Chirurgie de l'hôpital Lyon Sud

Pierre-Bénite, ,

Site Contact

Olivier GLEHEN, MD

[email protected]

04 78 86 43 53

Pierre-Bénite, France

Status

Recruiting

Address

Service de Dermatologie de l'hôpital Lyon Sud

Pierre-Bénite, ,

Site Contact

Stephane DALLE, MD

[email protected]

04 78 86 43 53

Pierre-Bénite, France

Status

Recruiting

Address

Service de Gynécologie de l'hôpital Lyon Sud

Pierre-Bénite, ,

Site Contact

Pierre Adrien BOLZE, MD

[email protected]

04 78 86 43 53

Pierre-Bénite, France

Status

Recruiting

Address

Service de Pneumologie de l'Hôpital Lyon Sud

Pierre-Bénite, ,

Site Contact

Sebastien COURAUD, MD

[email protected]

04 78 86 43 53