Clinical trial NCT05776342: Prognostic and Predictive Markers of Treatment Response in Patients With PAC.
Official title: Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Adenocarcinoma
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 4050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retro-prospective (diagnosis between 2003 and 2022) and prospective (diagnosis between 2023 and 2030) cohorts of patients with pancreatic adenocarcinoma

Brief summary: The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy,...) in patients with pancreatic adenocarcinoma. The effectiveness and tolerance of these treatments in current practice is also evaluated.

Detailed description: The modest efficacy of current therapies for pancreatic cancer calls for the development of prognostic factors to guide patient selection and clinical decision-making based on tumor aggressiveness and risk of death.

The aim of this study is to identify prognostic and predictive factors of response to treatments administered in pancreatic adenocarcinoma, based on a multicenter cohort established on a population derived from current clinical practice. By accurately stratifying patients according to their estimated survival, prognostic tools could aid therapeutic decisions and optimize patient selection in future clinical trials.

Eligibility criteria: Inclusion Criteria:

* Patient with histologically confirmed pancreatic adenocarcinoma.
* Disease at a resectable, borderline, locally advanced, initially metastatic, or recurrent stage after surgery
* Diagnosis between January 1, 2003, and December 31, 2030.
* First-line treatment with chemotherapy and/or radiotherapy and/or clinical trials.
* Age ≥ 18 years.
* Written informed consent

Exclusion Criteria:

* Patient under guardianship, curatorship, or judicial protection.
* Pregnant or breastfeeding women.
* Any medical, psychological, or social situation that could prevent compliance with the protocol as assessed by the investigator.
* Refusal to participate in the study

Primary outcomes:
measure: Overall Survival (OS) rate
timeFrame: Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)
Secondary outcomes:
measure: Progression-free survival (PFS) rate
timeFrame: Up to 7 years
measure: Number of patient with objective response rate
timeFrame: Up to 7 years
measure: Number of patient with stability rate
timeFrame: Up to 7 years
measure: Number of patient with tumor progression
timeFrame: Up to 7 years
measure: Number of patient with grade 3/4 treatment-related toxicities
timeFrame: Up to 7 years
measure: Number of patients who received maintenance treatment in the first-line
timeFrame: Up to 7 years
measure: Number of patients who received second and third-line treatments
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: CHU - Henri Mondor
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nancy
country: France
facility: HRU Nancy Site Brabois
city: Paris
country: France
facility: Hôpital Georges Pompidou
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Pontchaillou
city: Saint-Cloud
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: IHU - Institut de chirurgie guidée par l'imagerie
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
affiliation: CHRU de Besançon - Institut Régional Fédératif du Cancer (IRFC) de Franche-Comté
name: Angelique VIENOT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Claude-Huriez
name: Anthony Turpin, MD
role: PRINCIPAL_INVESTIGATOR
References: