Prognostic and Predictive Markers of Treatment Response in Patients With PAC.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatic Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma
Overview
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.
Primary outcome measures
- Overall Survival (OS) rate [Time frame: Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)]
Secondary outcome measures (7)
- Progression-free survival (PFS) rate [Time frame: Up to 7 years]
- Number of patient with objective response rate [Time frame: Up to 7 years]
- Number of patient with stability rate [Time frame: Up to 7 years]
- Number of patient with tumor progression [Time frame: Up to 7 years]
- Number of patient with grade 3/4 treatment-related toxicities [Time frame: Up to 7 years]
- Number of patients who received maintenance treatment in the first-line [Time frame: Up to 7 years]
- Number of patients who received second and third-line treatments [Time frame: Up to 7 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 15 centers
- CHU Jean Minjoz — Besançon
- Hôpital Beaujon — Clichy
- CHU - Henri Mondor — Créteil
- CHU Lille — Lille
- Centre Léon Bérard — Lyon
- HRU Nancy Site Brabois — Nancy
- Hôpital Georges Pompidou — Paris
- Hôpital Saint Antoine — Paris
- … and 7 more centers
Identifiers
NCT: NCT05776342 · CANOPE GB-121