Endometrial CancerPENDORNCT06603506
Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study
An observational study of Endometrial Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
This study comprises 3 stages: 1. Collection of tumor and blood samples. 2. Creation of organoid models based on tumor samples. 3. Development of functional tests to predict clinical response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- tumour and blood samples
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2024to 15 Oct 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with localized endometrial cancer
Who may be able to join
- Patient aged 18 years or more
- Patient with histologically confirmed, localized endometrial cancer, candidate for surgical treatment.
- Patient with localized endometrial cancer, presenting:
- A high-grade endometrioid histological type and/or
- P53 mutation and/or
- a non-endometrioid histological type regardless of P53 status.
- Patient affiliated to a social security scheme
- Information and signature of informed consent prior to any specific study procedure
Who cannot join
- Other active cancer less than 6 months old (with the exception of treated basal cell carcinoma of the skin).
- Patient deprived of liberty, under guardianship, or subject to a legal protection measure, or unable to express consent.
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
Gwenn LE GALL, Medical Doctor, 332031455050, g.legall@baclesse.unicancer.fr
About this study
This study comprises 3 stages:
- Collection of tumor and blood samples.
- Creation of organoid models based on tumor samples.
- Development of functional tests to predict clinical response to treatment.
- Conditions
- Endometrial Cancer
- Being tested
- tumour and blood samples
- Keywords
- endometrial cancer, organoide, PARP inhibitor
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumour and blood samplesOther
Tumour and blood samples
| Study group | Role | What they receive |
|---|---|---|
| tumour and blood collection | tumour and blood collection for realization ex vivo organoid models Receives: Other: tumour and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of establishment of exploitable tumor organoid lines
Rate of establishment of tumor organoid lines usable for predictive assays of response to PARP inhibitors.
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 posted19 Sep 2024
- Study start21 Nov 2024
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies 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
- 16 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
- NCT06603506
- Sponsor's protocol ID
- 2024-A01206-41
- Other IDs
- 2024-A01206-41
- Acronym
- PENDOR
- Status last verified
- Nov 2024
- First submitted
- 6 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gall GL, Cherifi F, Divoux J, Florent R, Christy F, Leconte A, San C, Devillers A, Desmartin G, Lecouflet L, Clarisse B, Ballesta S, Thorel L, Dubois B, Harter V, Rousseau N, Gaichies L, Martin-Francoise S, Le Brun JF, Dolivet E, Rouzier R, Jeanne C, Blanc-Fournier C, Figeac M, Leman R, Castera L, Poulain L, Weiswald LB, Joly F. The PENDOR study: establishment of a panel of patient-derived tumor organoids from endometrial cancer to assess efficacy of PARP inhibitors. BMC Cancer. 2025 Feb 11;25(1):244. doi: 10.1186/s12885-025-13590-6.
PubMed 39934735
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study
- ClinicalTrials.gov ID
- NCT06603506
- Acronym / sponsor ID
- PENDOR / 2024-A01206-41
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, organoide, PARP inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 19 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.
This study comprises 3 stages:
- Collection of tumor and blood samples.
- Creation of organoid models based on tumor samples.
- Development of functional tests to predict clinical response to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tumour and blood collection | – | Other: tumour and blood samplestumour and blood collection for realization ex vivo organoid models |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with localized endometrial cancer
Key inclusion criteria (8 listed)
- Patient aged 18 years or more
- Patient with histologically confirmed, localized endometrial cancer, candidate for surgical treatment.
- Patient with localized endometrial cancer, presenting:
- Patient affiliated to a social security scheme
- Information and signature of informed consent prior to any specific study procedure
Key exclusion criteria (2 listed)
- Other active cancer less than 6 months old (with the exception of treated basal cell carcinoma of the skin).
- Patient deprived of liberty, under guardianship, or subject to a legal protection measure, or unable to express consent.
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 |
|---|---|---|
| tumour and blood samplesTumour and blood samples | Other | tumour and blood collection |
Primary outcome
Rate of establishment of exploitable tumor organoid lines
Time frame: through study completion, an average of 3 years
Rate of establishment of tumor organoid lines usable for predictive assays of response to PARP inhibitors.
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 26 Nov 2024.
- Derived from this study: PubMed 39934735Gall GL, Cherifi F, Divoux J, Florent R, Christy F, Leconte A, San C, Devillers A, Desmartin G, Lecouflet L, Clarisse B, Ballesta S, Thorel L, Dubois B, Harter V, Rousseau N, Gaichies L, Martin-Francoise S, Le Brun JF, Dolivet E, Rouzier R, Jeanne C, Blanc-Fournier C, Figeac M, Leman R, Castera L, Poulain L, Weiswald LB, Joly F. The PENDOR study: establishment of a panel of patient-derived tumor organoids from endometrial cancer to assess efficacy of PARP inhibitors. BMC Cancer. 2025 Feb 11;25(1):244. doi: 10.1186/s12885-025-13590-6.
- Individual participant dataSharing planned: No
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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 Endometrial Cancer, 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 8 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 26 Nov 2024. 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 Gwenn LE GALL, Medical Doctor (+33231455050, g.legall@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 organoid lines (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?
On the ClinicalTrials.gov record for NCT06603506, which also lists 1 linked publication.
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 26 Nov 2024.