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

Sponsor

Centre Francois Baclesse (Other)

Overall Status

Recruiting

CT.gov ID

NCT03738267

Collaborator

French scientific group REFCOR (Other)

Enrollment

Locations

119.8

Anticipated Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Head and neck cancers that occurred during pregnancy

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Pregnancy Related

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Study on the Occurrence of Head and Neck Cancers During Pregnancy

Actual Study Start Date :

Nov 7, 2018

Anticipated Primary Completion Date :

Nov 1, 2028

Anticipated Study Completion Date :

Nov 1, 2028

Outcome Measures

Primary Outcome Measures

Serological status of patients [Through study completion, an average of 5 years]
Number of patients with positive or negative serological status for PVH (Papilloma Virus Humain) and EBV (Epstein-Barr Virus)
Characteristics pregnancy of patients [Through study completion, an average of 5 years]
Presence or absence of maternal-fetal diseases
Tumor characteristics of patients [Through study completion, an average of 5 years]
Histological type of cancer
Tumor characteristics of patients [Through study completion, an average of 5 years]
Localization of cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Chu Besancon	Besançon	France
2	Chu Bordeaux	Bordeaux	France
3	Centre François Baclesse	Caen	France
4	Chu Grenoble Alpes	Grenoble	France
5	Ap-Hp Tenon	Paris	France
6	Chu Poitiers	Poitiers	France
7	Chu Toulouse	Toulouse	France
8	Institut Gustave Roussy IGR	Villejuif	France

Sponsors and Collaborators

Centre Francois Baclesse
French scientific group REFCOR

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Francois Baclesse

ClinicalTrials.gov Identifier:

NCT03738267

Other Study ID Numbers:

2018-A01220-55

First Posted:

Nov 13, 2018

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Jul 21, 2021