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

Head and Neck Cancer Clinical Trial

— ORGAVADS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04261192
• Other study ID #: 2019-A03332-55
• Status: Recruiting
• Start date: July 3, 2020
• Est. completion date: February 2031

Study information

• Verified date: November 2023
• Source: Centre Francois Baclesse
• Contact: Vianney BASTIT, MD
• Phone: + 33 2 31 45 50 14
• Email: v.bastit[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2031
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Constitution of tumor and blood samples
Constitution of tumor and blood samples

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	CHU de Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of establishment of exploitable organoids tumor	Number of exploitable organoids tumor	5 years