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

NCT06612827 | Recruiting

• 1 other identifier: 2024-A01326-41
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Undifferentiated Carcinoma

Keywords

tumoroid; organoid

Outcome Measures

Primary Outcomes (1)

• Rate of establishment of exploitable tumor organoids

  Rate of establishment usable tumor organoids for predictive tests of response to treatment.

  through study completion, an average of 3 years

Study Arms (1)

Blood and tumor collection

Blood and tumor collection before treatment initiation

Other: organoid etablishment

Interventions

organoid etablishment 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

Blood and tumor collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient with undifferentiated primary carcinoma (UPC) with histological and immunohistochemical evidence, validated in a local and/or national UPC multidisciplinary consultation
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Centre François Baclesse

Caen, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor and serum samples

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

zoé NEVIERE, Medical Doctor

CONTACT

33231455050; z.neviere@baclesse.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: March 5, 2025
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2032
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)