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Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors (PACAomics)

Primary Purpose

Pancreatic Tumor

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

suspected pancreatic tumor

About this trial

This is an interventional other trial for Pancreatic Tumor focused on measuring pancreatic tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Suspicion of pancreatic adenocarcinoma
Patient > 18 years old
Social Security affiliation
Signed informed consent

Exclusion Criteria:

Patient in emergency situation
Major person being the object of a legal protective measure or unable to express its consent

Sites / Locations

Marine GILABERT, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

suspected pancreatic tumor

Arm Description

Realization of pancreatic tumor biopsy and blood samples

Outcomes

Primary Outcome Measures

Biomarkers

Genomics, transcriptomics and proteomics analyses to determine presence or absence of biomarkers

Secondary Outcome Measures

Histology

To determine the histologic characteristics of the pancreatic tumor

Full Information

NCT ID

NCT01692873

First Posted

September 14, 2012

Last Updated

August 10, 2018

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT01692873

Brief Title

Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors

Acronym

PACAomics

Official Title

Research for Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors - PACAomics / IPC 2011-004

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat. Most patients present at diagnosis a non resectable, locally advanced or metastatic disease, with a median survival of 12 month. The aim of this study is the identification of diagnosis biomarkers, predictive of the therapeutic response. This project investigate the use of molecular analyses applied to pancreatic tumor cells collected by microbiopsy under ultrasound-endoscopy, and blood cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Tumor

Keywords

pancreatic tumor

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

274 (Actual)

8. Arms, Groups, and Interventions

Arm Title

suspected pancreatic tumor

Arm Type

Experimental

Arm Description

Realization of pancreatic tumor biopsy and blood samples

Intervention Type

Procedure

Intervention Name(s)

suspected pancreatic tumor

Intervention Description

Realization of pancreatic surgery to obtain tumor biopsy and blood samples to realize biomarkers analyses.

Primary Outcome Measure Information:

Title

Biomarkers

Description

Genomics, transcriptomics and proteomics analyses to determine presence or absence of biomarkers

Time Frame

within twenty four hours

Secondary Outcome Measure Information:

Title

Histology

Description

To determine the histologic characteristics of the pancreatic tumor

Time Frame

within twenty four hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Suspicion of pancreatic adenocarcinoma Patient > 18 years old Social Security affiliation Signed informed consent Exclusion Criteria: Patient in emergency situation Major person being the object of a legal protective measure or unable to express its consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marine GILABERT, MD

Organizational Affiliation

Institut Paoli-Calmettes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marine GILABERT, MD

City

Marseille

ZIP/Postal Code

13009

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

36178036

Citation

Fraunhoffer NA, Abuelafia AM, Chanez B, Bigonnet M, Gayet O, Roques J, Chuluyan E, Dusetti N, Iovanna J. Inhibition of glucuronidation in pancreatic cancer improves gemcitabine anticancer activity. Cancer Commun (Lond). 2022 Nov;42(11):1212-1216. doi: 10.1002/cac2.12365. Epub 2022 Sep 30. No abstract available.

Results Reference

derived

PubMed Identifier

35848462

Citation

Fraunhoffer NA, Abuelafia AM, Dusetti N, Iovanna J. Limitation and challenges in using pancreatic cancer-derived organoids as a preclinical tool. Cancer Commun (Lond). 2022 Oct;42(10):1028-1031. doi: 10.1002/cac2.12335. Epub 2022 Jul 18. No abstract available.

Results Reference

derived

Links:

URL

http://www.institutpaolicalmettes.fr/

Description

official web site of the sponsor

Learn more about this trial

Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors

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