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

NCT03787056 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2021-07-16

No results posted yet for this study

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/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.

Conditions

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Follow up: at each visit scheduled (every 3 months) for the first 2 years, then every 6 months for 3 years * Relapse : withdrawn from the study and last progastrin measurement.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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Benoit YOU, MD · Hospices Civils de Lyon

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2028-01-04
Completion
2028-01-04

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03787056 on ClinicalTrials.gov