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

NCT ID: NCT06612827

Last Updated: 2025-12-24

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-05

Study Completion Date

2032-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Undifferentiated Carcinoma

Keywords

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tumoroid organoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood and tumor collection

Blood and tumor collection before treatment initiation

organoid etablishment

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre François Baclesse

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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zoé NEVIERE, Medical Doctor

Role: CONTACT

Phone: 33231455050

Email: [email protected]

Facility Contacts

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Zoé NEVIERE, MD

Role: primary

Other Identifiers

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2024-A01326-41

Identifier Type: -

Identifier Source: org_study_id