Establishment of Squamous Cell Organoids of the Head and Neck to Assess Their Response to Innovative Therapies

NCT04261192 | Recruiting

• 1 other identifier: 2019-A03332-55
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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 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

Keywords

Organoid

Outcome Measures

Primary Outcomes (1)

• Rate of establishment of exploitable organoids tumor

  Number of exploitable organoids tumor

  5 years

Interventions

Constitution of tumor and blood samples OTHER

Constitution of tumor and blood samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, classified T3Nx or T4Nx or T2N +, not previously treated;

You may qualify if:

• 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

You may not qualify if:

• Pregnant woman ;
• Persons deprived of their liberty or under guardianship (including curatorship);

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (2)

Centre François Baclesse

Caen, 14076, France

RECRUITING

CHU de Caen

Caen, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 36894916 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Vianney BASTIT, MD

CONTACT

+ 33 2 31 06 54 37; bastit-v@chu-caen.fr

Jean-Michel GRELLARD

CONTACT

+ 33 2 31 45 50 02; jm.grellard@baclesse.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 7, 2020
• Study Start: July 3, 2020
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)