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Prospective Multicenter Study Evaluating Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers

NCT05267912 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-12-16

No results posted yet for this study

Summary

* PDOs are tridimensional multicellular structures expanded in vitro which retain the genotypic and phenotypic features of their tissue or tumor of origin. PDOs can be exposed to a panel of drugs (chemotherapy, hormonal therapy, targeted therapy) in order to study their sensitivity to each agent (or combination of agents) tested ('chemogram'). Recent studies showed that PDOs can accurately predict the response to treatment of solid tumors and could therefore inform clinical decision on the best therapeutic option for each patient.
* ORGANOTREAT is a multicenter prospective study program of organoid-based precision oncology encompassing 3 studies: ORGANOTREAT-01, a pilot study restricted to advanced CRC, and ORGANOTREAT-02A and -2B, two Phase 2 studies in advanced solid cancers.

Conditions

  • Advanced, Pretreated Solid Tumors

Interventions

PROCEDURE

Biopsy

We need a biopsy for PDO: PDOs are tridimensional multicellular structures expanded in vitro which retain the genotypic and phenotypic features of their tissue or tumor of origin. PDOs can be exposed to a panel of drugs (chemotherapy, hormonal therapy, targeted therapy) in order to study their sensitivity to each agent (or combination of agents) tested ('chemogram'). Recent studies showed that PDOs can accurately predict the response to treatment of solid tumors and could therefore inform clinical decision on the best therapeutic option for each patient.

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Fanny Jaulin, PhD · Gustave Roussy cancer campus

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2028-01-18
Completion
2029-01-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05267912 on ClinicalTrials.gov