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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Retro-prospective (diagnosis between 2003 and 2022) and prospective (diagnosis between 2023 and 2030) cohorts of patients with pancreatic adenocarcinoma

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)

Secondary outcomes

1

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

Time frame
Up to 7 years
2

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.

Time frame
Up to 7 years
3

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.

Time frame
Up to 7 years
4

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.

Time frame
Up to 7 years

Other outcomes

Sponsors and contacts

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