Development of Tumor Organoids From Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions (OCAPI)

December 23, 2025 updated by: Centre Francois Baclesse
The study is based on the constitution of a collection of tumor and blood samples for the development of tumoroid for functional tests to predict clinical response to treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with undifferentiated primary carcinoma (UPC) with indication for 1st-line treatment

Description

Inclusion Criteria:

  • Patient with undifferentiated primary carcinoma (UPC) with histological and immunohistochemical evidence, validated in a local and/or national UPC multidisciplinary consultation
  • Patient with indication for systemic 1st-line treatment at the time of inclusion. Treatment may already have begun at the time of inclusion, but within the limit of 2 treatment cycles administered.
  • Patient with life expectancy greater than 3 months
  • Patient of legal age
  • Patient affiliated to a social security scheme
  • Signature of informed consent prior to any specific study procedure

Exclusion Criteria:

  • Persons deprived of their liberty or under guardianship (including curatorship)
  • Pregnant or breast-feeding patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Blood and tumor collection
Blood and tumor collection before treatment initiation
Other: organoid etablishment

Prior to initiation of 1st-line therapy:

  • Collection of an additional study-specific tumor sample for tumoroid analysis (1 fresh tumor sample)
  • A blood test blood a for tumoroid realization and :
  • Analysis of ex vivo tumoroid response to treatment and correlation with patient response in vivo
  • Analysis of correlation between in vivo and ex vivo tumor characteristics
  • Analysis of first- and second-line survival rates and overall survival

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of establishment of exploitable tumor organoids
Time Frame: through study completion, an average of 3 years
Rate of establishment usable tumor organoids for predictive tests of response to treatment.
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

December 15, 2032

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01326-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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