Study Stopped
number of inclusions not reached
Study on the Occurrence of Head and Neck Cancers During Pregnancy
REFCORbirth
1 other identifier
observational
14
1 country
8
Brief Summary
Head and neck cancers that occurred during pregnancy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2018
CompletedStudy Start
First participant enrolled
November 7, 2018
CompletedFirst Posted
Study publicly available on registry
November 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2025
CompletedSeptember 26, 2025
September 1, 2025
6.9 years
November 6, 2018
September 23, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
Characteristics pregnancy of patients
Presence or absence of maternal-fetal diseases
Through study completion, an average of 5 years
Tumor characteristics of patients
Histological type of cancer
Through study completion, an average of 5 years
Tumor characteristics of patients
Localization of cancer
Through study completion, an average of 5 years
Eligibility Criteria
Patients with cancers of Head and Neck that occurred during pregnancy
You may qualify if:
- 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
You may not qualify if:
- Any other neoplastic antecedent
- Person subject to a legal protection measure or unable to express their consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- French scientific group REFCORcollaborator
Study Sites (8)
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, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2018
First Posted
November 13, 2018
Study Start
November 7, 2018
Primary Completion
September 23, 2025
Study Completion
September 23, 2025
Last Updated
September 26, 2025
Record last verified: 2025-09