Prognostic and Predictive Markers of Treatment Response in Patients With PAC.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma

Conditions
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Pancreatic Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) rate | Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of death regardless of the cause. Living or lost to follow-up patients will be censored at the date of the last news | Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) rate | Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of first progression or date of death regardless of the cause. Living patients without progression or lost to follow-up will be censored at the date of the last news | Up to 7 years | 
| Number of patient with objective response rate | Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments. | Up to 7 years | 
| Number of patient with stability rate | Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments. | Up to 7 years | 
| Number of patient with tumor progression | Evaluation according to RECIST v1.1, Choi or iRECIST criteria. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments. | Up to 7 years | 
| Number of patient with grade 3/4 treatment-related toxicities | Toxicity rates according to CTCAE v5.0 classification. Study the population followed for pancreatic adenocarcinoma according to tumor stages (localized, borderline, locally advanced, metastatic or recurrent after surgery) and according to treatments. | Up to 7 years | 
| Number of patients who received maintenance treatment in the first-line | Study the profiles of patients receiving maintenance treatment in 1st-line chemotherapy | Up to 7 years | 
| Number of patients who received second and third-line treatments | Study the profiles of patients receiving 2nd and 3rd lines of chemotherapy | Up to 7 years |