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NCT03738267 Clinical Trial

Study on the Occurrence of Head and Neck Cancers During Pregnancy

Head and Neck Cancer Clinical Trial

— REFCORbirth  

Official title:
Study on the Occurrence of Head and Neck Cancers During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03738267
Other study ID # 2018-A01220-55
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 7, 2018
Est. completion date November 2028

Study information
Verified date July 2021
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Head and neck cancers that occurred during pregnancy

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date November 2028
Est. primary completion date November 2028
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 year old woman or over at the time of participation - PS 0 -2 - Cancer diagnosed (biopsy date) from 01/01/2010 between the second week of pregnancy and the 12 months postpartum. - Primitive may concern the following sites: oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, prevalent lymphadenopathy, nasal cavity, salivary glands, dental tumors, ear tumors, paragangliomas optic pathways, facial sinus / facial mass, nose, ear and other head and neck - All histologies (epithelial tumors, sarcomas, mucosal melanomas, embryonic tumors, undifferentiated tumors) - Patient receiving or having received a specific oncological treatment among surgery, radiotherapy, chemotherapy, hormone therapy. - All stages allowed: localized stages and metastatic stages immediately. - No opposition of the patient to participate in this study Exclusion Criteria: - Any other neoplastic antecedent - Exclusion of metastases at the level of the VADS of another primitive than a cancer of the VADS - Exclusion of hematological tumors (lymphoma) and glial tumors - Person subject to a legal protection measure or unable to express their consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Chu Besancon Besançon
France Chu Bordeaux Bordeaux
France Centre François Baclesse Caen
France Chu Grenoble Alpes Grenoble
France Ap-Hp Tenon Paris
France Chu Poitiers Poitiers
France Chu Toulouse Toulouse
France Institut Gustave Roussy IGR Villejuif

Sponsors (2)
Lead Sponsor Collaborator
Centre Francois Baclesse French scientific group REFCOR

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serological status of patients Number of patients with positive or negative serological status for PVH (Papilloma Virus Humain) and EBV (Epstein-Barr Virus) Through study completion, an average of 5 years
Primary Characteristics pregnancy of patients Presence or absence of maternal-fetal diseases Through study completion, an average of 5 years
Primary Tumor characteristics of patients Histological type of cancer Through study completion, an average of 5 years
Primary Tumor characteristics of patients Localization of cancer Through study completion, an average of 5 years
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