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NCT Number: NCT06612827

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

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.

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Key information

Conditions

Undifferentiated Carcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

zoé NEVIERE, Medical Doctor

CONTACT

[email protected]

33231455050

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: OCAPI

Important dates

Study start
2025
Primary completion
2028
Study completion
2032
First posted
Sep 25, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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