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

  • STATUS
    Recruiting
  • End date
    Jan 4, 2028
  • participants needed
    410
  • sponsor
    Hospices Civils de Lyon
Updated on 25 July 2021
cancer
remission
ascites
cyclophosphamide
tyrosine
lymphoma
rituximab
monoclonal antibodies
prednisone
tumor markers
carcinoma
tumor growth
squamous cell carcinoma
BRAF
cavity
metastasis
hormone therapy
ROS1
EGFR
primary tumor
lobular carcinoma
docetaxel
brachytherapy
gastric cancer
gastric carcinoma
cancer treatment
uterine disease
primary cancer
concurrent chemotherapy
cancer chemotherapy
diffuse large b-cell lymphoma
b-cell lymphoma
temozolomide
adenocarcinoma
breast carcinoma
bladder cancer
adjuvant chemotherapy
withdrawn
invasive bladder cancer
large b-cell lymphoma
r-chop
transitional cell carcinoma
bladder tumor
bladder carcinoma
superficial bladder cancer
immunomodulator
ductal carcinoma
immunostimulants
immunomodulators
nephrectomy
carcinosarcoma
endometrial adenocarcinoma
head and neck carcinoma
tumor debulking
breast ductal carcinoma
lung carcinoma
chop regimen
immunologic adjuvant
braf v600e mutation
interval debulking surgery

Summary

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/-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.

Chronic activation of the WNT/-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.

Details
Condition Ovarian Cancer, Ewing's Family Tumors, Liver Cancer, Kidney Cancer, Kidney Disease, Digestive System Neoplasms, Prostate Cancer, Glioblastoma multiforme, Islet Ce417ll Cancer, Prostate Disorders, Recurrent Ovarian Cancer, Breast Cancer, Cancer/Tumors, HEPATIC NEOPLASM, cancer of the esophagus, cancer of the pancreas, Rectal disorder, LIVER DISEASE, prostate carcinoma, Bladder Cancer, Pulmonary Disease, colorectal neoplasm, urinary tract neoplasm, bladder disorder, cancer, ovarian, Bladder Disorders, Esophageal Cancer, Neoplasms, Lung Neoplasm, Gastric Cancer, Bladder Carcinoma, carcinoma lung, Lymphoma, B-Cell, b-cell lymphomas, Renal Cancer, Lung Disease, cancer ovarian, Liver Disorders, malignancies, Melanoma, Kidney Disease (Pediatric), cancer, pancreatic, bladder tumor, cancer, breast, b cell lymphomas, cancer, colorectal, Prostate Cancer, Early, Recurrent, tumors, colorectal, b cell lymphoma, Metastatic Melanoma, skin cancer, liver cancers, Colorectal Cancer, Malignant neoplasm of kidney, ovarian carcinomas, Skin Cancer, head and neck cancer, Pancreatic Cancer, Liver Disease, esophagus cancer, malignancy, Lymphoma, breast carcinoma, B-Cell Lymphoma, Pancreatic disorder, Rectal Disorders, carcinoma of the bladder, Ovarian disorder, melanoma, primary malignant neoplasm, cancer of the ovary, malignant tumor, prostate cancers, pancreatic cancers, cancer of the head and neck, cancer, liver, Colon cancer; rectal cancer, Endometrial Carcinoma, Cancer (Pediatric), Urothelial Cancer, colorectal cancers, Non-Hodgkin's Lymphoma, oesophageal carcinoma, malignant tumors, Esophageal Diseases, Gastric Carcinoma, Esophageal Disorders, Lung Cancer, Stomach Cancer, Urologic Cancer, Head and Neck Cancer, oesophageal cancer, cancer, hepatic, Ovarian Function, ovarian tumors, Colon Cancer Screening, Endometrial Cancer, Pancreatic Disorders, primary cancer, Malignant Melanoma, cancer, renal, cancers, lung carcinoma, Stomach Discomfort, Esophageal Carcinoma, cancer, hepatocellular, Gastropathy, colorectal tumor, Bronchial Neoplasm, Uterine Cancer, Malignant neoplasm of prostate, bladder cancer, glioblastoma, Nephropathy, gastric cancers, Neoplasm of unspecified nature of digestive system, Glioblastoma Multiforme, Prostatic disorder, HEPATOCELLULAR CARCINOMA, Cancer, Breast Cancer Diagnosis
Treatment Blood draws
Clinical Study IdentifierNCT03787056
SponsorHospices Civils de Lyon
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Indication of a treatment strategy with curative intent (surgery; radiotherapy; chemotherapy; hormonotherapy; targeted agents)
Patient nave 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 nave 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
Intestinal-type adenocarcinoma, or
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
Localized prostate cancer with high risk features : StageT2b , T2c or T3 and/or Gleason >= 4+3 and/or PSA >= 20 and/or N+
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 nave 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
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
NSCLC histology only
Stage I-II according to 8th TNM classification
Stage IIIA-B according to 8th TNM classification
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
Lieberkhn adenocarcinoma associated with metastases planned to be treated with peri-operative chemotherapy +/- targeted agent and interval surgery
Head and neck carcinomas
All cohorts
Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx, larynx
Curative intent treatment patients cohort
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
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
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
st 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
Planned to be treated with surgical resection, followed by adjuvant temozolomide and radiotherapy
Endometrial adenocarcinomas
Non-curative intent patients cohort
Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell, undifferentiated carcinoma and carcinosarcoma) cancers
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
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
Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin, Prednisone)
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