Head and Neck CancerORGAVADSNCT04261192
Establishment of Squamous Cell Organoids of the Head and Neck to Assess Their Response to Innovative Therapies
An observational study of Head and Neck Cancer, run by Centre Francois Baclesse at 2 sites in France.
Trial summary
The emergence of tumor organoid cultures in recent years has made it possible to widen the repertoire of available preclinical tumor models and to bridge the gap between cell lines and tumors of xenografted patients in mice (PDXs).These organoids have the advantages of being able to be amplified fairly quickly after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Constitution of tumor and blood samples
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jul 2020to Feb 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 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, classified T3Nx or T4Nx or T2N +, not previously treated;
Who may be able to join
- Patient over 18 years of age;
- Patient with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, classified T3Nx or T4Nx or T2N +, not previously treated;
- Patient to be treated by surgery;
- Patient affiliated to a social security scheme;
- No opposition to participate in the study
Who cannot join
- Pregnant woman ;
- Persons deprived of their liberty or under guardianship (including curatorship);
- History of malignant pathology preceding inclusion (apart from basal cell carcinomas of the skin and carcinomas in situ of the cervix treated surgically) or concomitant at inclusion (synchronous tumor)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre François Baclesse
Caen, 14076
Audrey LARNAUDIE, MD, + 33 2 31 45 50 50, a.larnaudie@baclesse.unicancer.fr
Jean-Michel GRELLARD, + 33 2 31 45 50 02, jm.grellard@baclesse.unicancer.fr
- Recruiting
CHU de Caen
Caen
Vianney BASTIT, MD, bastit-v@chu-caen.fr
Emmanuel BABIN, PhD
About this study
The emergence of tumor organoid cultures in recent years has made it possible to widen the repertoire of available preclinical tumor models and to bridge the gap between cell lines and tumors of xenografted patients in mice (PDXs).These organoids have the advantages of being able to be amplified fairly quickly after resection of the tumor, of having unlimited proliferation potential, a high rate of establishment success, and the possibility of being transfected and cryopreserved. These characteristics therefore allow them to summarize the clinical spectra of cancers, but also to be models for studying tumor progression as has been done with organoids for colorectal cancer. They are also very close morphologically and genetically to the tumor from which they derive.Finally, clinical trials are underway to determine whether the organoids of mammary, pulmonary and colorectal cancers can predict the response to patients' treatments and guide the therapeutic decision.It would therefore be possible to test multiple treatments on different samples. This would allow screening of a panel of treatments on a given tumor type but also to test a treatment ex vivo before administering it to the patient in vivo. This prospect is very interesting in particular in the tumors of the VADS where more than two thirds of the operated patients will benefit from a complementary treatment by radiotherapy and / or chemotherapy whose consequences can be important. Despite this adjuvant management, up to 30% of patients will relapse, highlighting a variable tumor chemosensitivity. This screening could make it possible to refine the choice of treatments adapted to each patient and thus limit the undesirable effects.The feasibility of establishing head and neck squamous cell organoid lines seems encouraging, with organoids derived from squamous cell carcinoma of the oral cavity and oropharynx having been recently established.
- Conditions
- Head and Neck Cancer
- Being tested
- Constitution of tumor and blood samples
- Keywords
- Organoid
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constitution of tumor and blood samplesOther
Constitution of tumor 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 organoids tumor
Number of exploitable organoids tumor
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start3 Jul 2020
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2032 (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 Head and Neck 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
- 120 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
- NCT04261192
- Sponsor's protocol ID
- 2019-A03332-55
- Acronym
- ORGAVADS
- Status last verified
- May 2026
- First submitted
- 6 Feb 2020
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perreard M, Florent R, Divoux J, Grellard JM, Lequesne J, Briand M, Clarisse B, Rousseau N, Lebreton E, Dubois B, Harter V, Lasne-Cardon A, Drouet J, Johnson A, Le Page AL, Bazille C, Jeanne C, Figeac M, Goardon N, Vaur D, Micault E, Humbert M, Thariat J, Babin E, Poulain L, Weiswald LB, Bastit V. ORGAVADS: establishment of tumor organoids from head and neck squamous cell carcinoma to assess their response to innovative therapies. BMC Cancer. 2023 Mar 9;23(1):223. doi: 10.1186/s12885-023-10692-x.
PubMed 36894916
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Squamous Cell Organoids of the Head and Neck to Assess Their Response to Innovative Therapies
- ClinicalTrials.gov ID
- NCT04261192
- Acronym / sponsor ID
- ORGAVADS / 2019-A03332-55
- Conditions
- Head and Neck Cancer
- Keywords
- Organoid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 7 Feb 2020 (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 emergence of tumor organoid cultures in recent years has made it possible to widen the repertoire of available preclinical tumor models and to bridge the gap between cell lines and tumors of xenografted patients in mice (PDXs).These organoids have the advantages of being able to be amplified fairly quickly after resection of the tumor, of having unlimited proliferation potential, a high rate of establishment success, and the possibility of being transfected and cryopreserved. These characteristics therefore allow them to summarize the clinical spectra of cancers, but also to be models for studying tumor progression as has been done with organoids for colorectal cancer. They are also very close morphologically and genetically to the tumor from which they derive.Finally, clinical trials are underway to determine whether the organoids of mammary, pulmonary and colorectal cancers can predict the response to patients' treatments and guide the therapeutic decision.It would therefore be possible to test multiple treatments on different samples. This would allow screening of a panel of treatments on a given tumor type but also to test a treatment ex vivo before administering it to the patient in vivo. This prospect is very interesting in particular in the tumors of the VADS where more than two thirds of the operated patients will benefit from a complementary treatment by radiotherapy and / or chemotherapy whose consequences can be important. Despite this adjuvant management, up to 30% of patients will relapse, highlighting a variable tumor chemosensitivity. This screening could make it possible to refine the choice of treatments adapted to each patient and thus limit the undesirable effects.The feasibility of establishing head and neck squamous cell organoid lines seems encouraging, with organoids derived from squamous cell carcinoma of the oral cavity and oropharynx having been recently established.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, classified T3Nx or T4Nx or T2N +, not previously treated;
Key inclusion criteria (5 listed)
- Patient over 18 years of age;
- Patient with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, classified T3Nx or T4Nx or T2N +, not previously treated;
- Patient to be treated by surgery;
- Patient affiliated to a social security scheme;
- No opposition to participate in the study
Key exclusion criteria (3 listed)
- Pregnant woman ;
- Persons deprived of their liberty or under guardianship (including curatorship);
- History of malignant pathology preceding inclusion (apart from basal cell carcinomas of the skin and carcinomas in situ of the cervix treated surgically) or concomitant at inclusion (synchronous tumor)
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 |
|---|---|---|
| Constitution of tumor and blood samplesConstitution of tumor and blood samples | Other | – |
Primary outcome
Rate of establishment of exploitable organoids tumor
Time frame: 5 years
Number of exploitable organoids tumor
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 12 May 2026.
- Derived from this study: PubMed 36894916Perreard M, Florent R, Divoux J, Grellard JM, Lequesne J, Briand M, Clarisse B, Rousseau N, Lebreton E, Dubois B, Harter V, Lasne-Cardon A, Drouet J, Johnson A, Le Page AL, Bazille C, Jeanne C, Figeac M, Goardon N, Vaur D, Micault E, Humbert M, Thariat J, Babin E, Poulain L, Weiswald LB, Bastit V. ORGAVADS: establishment of tumor organoids from head and neck squamous cell carcinoma to assess their response to innovative therapies. BMC Cancer. 2023 Mar 9;23(1):223. doi: 10.1186/s12885-023-10692-x.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Centre Francois Baclesse at 2 sites 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 5 inclusion and 3 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Vianney BASTIT, MD (+ 33 2 31 06 54 37, bastit-v@chu-caen.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 organoids tumor (time frame: 5 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 NCT04261192, 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 12 May 2026.