Head and Neck CancerREFCORbirthNCT03738267
Study on the Occurrence of Head and Neck Cancers During Pregnancy
An observational study of Head and Neck Cancer and Pregnancy Related, run by Centre Francois Baclesse at 8 sites in France.
Trial summary
Head and neck cancers that occurred during pregnancy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Head and Neck Cancer, Pregnancy Related
- How many people
- 14 participants
- Where
- 8 sitesFrance
- Study dates
- 7 Nov 2018to 23 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancers of Head and Neck that occurred during pregnancy
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Chu Besancon
Besançon
Chu Bordeaux
Bordeaux
Centre François Baclesse
Caen
Chu Grenoble Alpes
Grenoble
Ap-Hp Tenon
Paris
Chu Poitiers
Poitiers
Chu Toulouse
Toulouse
Institut Gustave Roussy IGR
Villejuif
About this study
Head and neck cancers that occurred during pregnancy
- Conditions
- Head and Neck Cancer, Pregnancy Related
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological status of patients
Number of patients with positive or negative serological status for PVH (Papilloma Virus Humain) and EBV (Epstein-Barr Virus)
Measured: Through study completion, an average of 5 years
Characteristics pregnancy of patients
Presence or absence of maternal-fetal diseases
Measured: Through study completion, an average of 5 years
Tumor characteristics of patients
Histological type of cancer
Measured: Through study completion, an average of 5 years
Tumor characteristics of patients
Localization of cancer
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start7 Nov 2018
- Primary completion23 Sep 2025
- Study completion23 Sep 2025 (estimated)
Why it stopped: number of inclusions not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- French scientific group REFCOR
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738267
- Sponsor's protocol ID
- 2018-A01220-55
- Acronym
- REFCORbirth
- Status last verified
- Sep 2025
- First submitted
- 6 Nov 2018
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Occurrence of Head and Neck Cancers During Pregnancy
- ClinicalTrials.gov ID
- NCT03738267
- Acronym / sponsor ID
- REFCORbirth / 2018-A01220-55
- Conditions
- Head and Neck Cancer, Pregnancy Related
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: number of inclusions not reached
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- French scientific group REFCOR
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Head and neck cancers that occurred during pregnancy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancers of Head and Neck that occurred during pregnancy
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serological status of patients
Time frame: 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
Time frame: Through study completion, an average of 5 years
Presence or absence of maternal-fetal diseases
Tumor characteristics of patients
Time frame: Through study completion, an average of 5 years
Histological type of cancer
Tumor characteristics of patients
Time frame: Through study completion, an average of 5 years
Localization of cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Pregnancy Related, run by Centre Francois Baclesse at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological status of patients (time frame: Through study completion, an average of 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.