RecruitingNot ApplicableNCT03787056

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


Sponsor

Hospices Civils de Lyon

Enrollment

410 participants

Start Date

Dec 4, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is measuring blood levels of a protein called progastrin — a molecule linked to cell growth — in patients diagnosed with various cancers, both at the time of diagnosis and throughout their treatment. The goal is to find out whether progastrin levels at diagnosis can predict outcomes, and whether changes in these levels during treatment can signal whether the cancer is responding. This could eventually help doctors use progastrin as a simple blood-based tool to monitor how well cancer treatment is working. **You may be eligible if...** - You have been diagnosed with one of the following cancers confirmed by biopsy or lab test: breast, stomach, kidney, prostate, lung (NSCLC or SCLC), liver (hepatocellular carcinoma), colorectal, or head and neck cancer - You are willing to provide blood samples at the required time points **You may NOT be eligible if...** - Your cancer type is not included in the study's listed cancer categories - Your diagnosis has not been confirmed by pathology or cytology - You are unable to provide blood samples at the required visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood 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


Locations(17)

Service de NEURO-ONCOLOGIE du Groupement Hospitalier EST

Bron, France

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

Lyon, France

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

Lyon, France

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

Lyon, France

Service d'Urologie de l'Hôpital E. Herriot

Lyon, France

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

Lyon, France

Service de Gynécologie du Groupement Hospitalier Est

Lyon, France

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

Lyon, France

Service de Pneumologie du Groupement Hospitalier Est

Lyon, France

Service d'Hématologie de l'Hôpital Lyon Sud

Pierre-Bénite, France

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

Pierre-Bénite, France

Service d'Oncologie médicale du Centre hospitalier Lyon Sud

Pierre-Bénite, France

Service d'Urologie de l'hôpital Lyon Sud

Pierre-Bénite, France

Service de Chirurgie de l'hôpital Lyon Sud

Pierre-Bénite, France

Service de Dermatologie de l'hôpital Lyon Sud

Pierre-Bénite, France

Service de Gynécologie de l'hôpital Lyon Sud

Pierre-Bénite, France

Service de Pneumologie de l'Hôpital Lyon Sud

Pierre-Bénite, France

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NCT03787056


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