Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

NCT ID: NCT05380414

Last Updated: 2023-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2027-09-01

Brief Summary

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The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.

Detailed Description

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Conditions

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Metastatic Pancreatic Cancer Advanced Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Metastatic/advanced PDAC Patients

Tumor samples

Group Type EXPERIMENTAL

Tumor samples (archival FFPE) and blood samples

Intervention Type BIOLOGICAL

Molecular screening

Interventions

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Tumor samples (archival FFPE) and blood samples

Molecular screening

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female patient \> 18 years
* metastatic or advanced PDAC
* Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
* Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
* Life expectancy \> 3 months
* PS score 0 or 1.

Exclusion Criteria

* Curative therapy available
* Any condition contraindicated with blood sampling procedures required by the protocol.
* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Leon Berard

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe CASSIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

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Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe CASSIER, MD, PhD

Role: CONTACT

0426556833

Facility Contacts

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Philippe CASSIER, MD, PhD

Role: primary

0426556835

Other Identifiers

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ET21-399 GENOPANC

Identifier Type: -

Identifier Source: org_study_id

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