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

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 Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Constitution of tumor and blood samples

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Jean-Michel GRELLARD; Phone Number: + 33 2 31 45 50 02; Email: jm.grellard@baclesse.unicancer.fr
• Study Contact Backup: Name: Vianney BASTIT, MD; Phone Number: + 33 2 31 06 54 37; Email: bastit-v@chu-caen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • CHU de Caen
    • Principal Investigator: Emmanuel BABIN, PhD
    • Contact: Vianney BASTIT, MD; Email: bastit-v@chu-caen.fr
  • Caen, France, 14076
    • Recruiting
    • Centre Francois Baclesse
    • Contact: Jean-Michel GRELLARD; Phone Number: + 33 2 31 45 50 02; Email: jm.grellard@baclesse.unicancer.fr
    • Sub-Investigator: Audrey LASNE-CARDON, MD
    • Sub-Investigator: Juliette THARIAT, PhD
    • Sub-Investigator: Alisson JOHNSON, MD
    • Contact: Audrey LARNAUDIE, MD; Phone Number: + 33 2 31 45 50 50; Email: a.larnaudie@baclesse.unicancer.fr
    • Principal Investigator: Audrey LARNAUDIE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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;

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of establishment of exploitable organoids tumor	Number of exploitable organoids tumor	5 years

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2032

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Organoid
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 2019-A03332-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No