Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients
ONCOPRO
1 other identifier
interventional
410
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Dec 2018
Longer than P75 for not_applicable cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2018
CompletedStudy Start
First participant enrolled
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 4, 2028
July 16, 2021
July 1, 2021
9.1 years
October 26, 2018
July 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
Progastrin concentration in plasma samples will be measured with an ELISA Kit (CancerREAD LAB) provided by ECS Progastrin.
At baseline
Secondary Outcomes (15)
Longitudinal kinetic of progastrin values during treatments, assessed by modeled kinetic parameters of interest
6 years
Nycthemeral and weekly and post-operative progastrin variations
every 3 hours within 24 hours for the Nycthemeral cohort, and every week for 2 or 3 weeks for the weekly cohort
Determinants of progastrin serum values: hepatic function
6 years
Determinants of progastrin serum values: renal function
6 years
Determinants of progastrin serum values: age
at the inclusion
- +10 more secondary outcomes
Study Arms (1)
Cancer patients
OTHER420 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
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
Eligibility Criteria
You may qualify if:
- 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).
- Indication of a treatment strategy with no curative intent (radiotherapy; chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery, …)
- 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:
- +62 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Publications (1)
You B, Couraud S, Ceruse P, Badet L, Paparel P, Durand A, Guillet M, Merle P, Lescuyer G, Philip CA, Ducray F, Pioche M, Karlin L, Lifante JC, Glehen O, Bolze PA, Chauvenet M, Langlois-Jacques C, Subtil F, Piecyk M, Carrot A, Joubert D, Prieur A, Vire B, Calattini S, Payen L. Diagnostic value of the wnt target and cancer-associated blood biomarker hPG80: ONCOPRO case-control prospective study. Biomark Res. 2025 Jul 1;13(1):91. doi: 10.1186/s40364-025-00793-z.
PMID: 40598473DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benoit YOU, MD
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2018
First Posted
December 26, 2018
Study Start
December 4, 2018
Primary Completion (Estimated)
January 4, 2028
Study Completion (Estimated)
January 4, 2028
Last Updated
July 16, 2021
Record last verified: 2021-07