Undifferentiated CarcinomaOCAPINCT06612827
Development of Tumor Organoids From Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions
An observational study of Undifferentiated Carcinoma, run by Centre Francois Baclesse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undifferentiated Carcinoma
- What is being tested?
- organoid etablishment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2025to 15 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with undifferentiated primary carcinoma (UPC) with indication for 1st-line treatment
Who may be able to join
- 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
Who cannot join
- Persons deprived of their liberty or under guardianship (including curatorship)
- Pregnant or breast-feeding patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre François Baclesse
Caen
Zoé NEVIERE, MD, 33231455050, z.neviere@baclesse.unicancer.fr
About this study
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
- Being tested
- organoid etablishment
- Keywords
- tumoroid, organoid
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
organoid etablishmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Blood and tumor collection | Blood and tumor collection before treatment initiation Receives: Other: organoid etablishment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of establishment of exploitable tumor organoids
Rate of establishment usable tumor organoids for predictive tests of response to treatment.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start5 Mar 2025
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612827
- Sponsor's protocol ID
- 2024-A01326-41
- Acronym
- OCAPI
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Tumor Organoids From Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions
- ClinicalTrials.gov ID
- NCT06612827
- Acronym / sponsor ID
- OCAPI / 2024-A01326-41
- Conditions
- Undifferentiated Carcinoma
- Keywords
- tumoroid, organoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2032 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood and tumor collection | – | Other: organoid etablishmentBlood and tumor collection before treatment initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with undifferentiated primary carcinoma (UPC) with indication for 1st-line treatment
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Persons deprived of their liberty or under guardianship (including curatorship)
- Pregnant or breast-feeding patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| organoid etablishmentPrior 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 | Other | Blood and tumor collection |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undifferentiated Carcinoma, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zoé NEVIERE, Medical Doctor (33231455050, z.neviere@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of establishment of exploitable tumor organoids (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.