Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity CancerNCT07337122
Collagen Matrix in Oral Cancer Surgery
An observational study of Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer and Oropharynx Squamous Cell Carcinoma, run by SAYAH Charline at 1 site in France.
Trial summary
This study tend to evaluate postoperative phonation and swallowing after oncologic surgery of the oral cavity or oropharynx with application of a collagen matrix (Tachosil®). Patients are asked to complete a questionnaire the day before the surgery and at 1 and 6 months after. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharynx Squamous Cell Carcinoma, Oropharynx Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 16 Nov 2020to 31 Mar 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants were selected among patients presenting to the ENT department of the University Hospital of Besançon for a suspected lesion of the oral cavity or oropharynx.
Who may be able to join
- Age ≥18 years
- Histologically confirmed squamous cell carcinoma or other malignant tumor of the oral cavity and/or oropharynx
- Performance status (PS) 0-2
- Tumor stages for which surgical resection was indicated (T1-T3)
- Patients receiving or not receiving postoperative adjuvant radiotherapy
Who cannot join
- Legal incapacity or limited legal capacity
- Inability or anticipated poor compliance with study procedures
- Missing questionnaire data
- Congenital or acquired swallowing disorders (neurological or neuromuscular disease)
- Congenital or acquired speech disorders (neurological or neuromuscular disease)
- Death during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Swallowing and Voice Outcomes After Collagen Matrix Reconstruction in Oral and Oropharyngeal Cancer Surgery
This study tend to evaluate postoperative phonation and swallowing after oncologic surgery of the oral cavity or oropharynx with application of a collagen matrix (Tachosil®). Patients are asked to complete a questionnaire the day before the surgery and at 1 and 6 months after.
Read the detailed description
It was an interventional study with a single Group.
- Conditions
- Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharynx Squamous Cell Carcinoma, Oropharynx Cancer
- Keywords
- oral cancer, phonation, swallowing, voice, glossectomy, reconstruction, tachosil
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patient were ≥18 years with a histologically confirmed squamous cell carcinoma or other malignant tumor of the oral cavity and/or oropharynx with surgical resection indicated (T1-T3). The performance status was betwen 0 and 2. Patients were receiving or not receiving postoperative adjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing evaluation
We use the Deglutition Handicap Index questionnaire to evaluative swallowing before and after surgery. Patients completed the questionnaires the day before surgery, and at 1 month and 6 months postoperatively.
Measured: From enrollment (the day before the surgery) to 6 months postoperatively.
Voice evaluation
We use the Voice Handicap Index questionnaire to evaluate the phonatione before and after surgery. Patients completed the questionnaires the day before surgery, and at 1 month and 6 months postoperatively.
Measured: From enrollment (the day before the surgery) to 6 months postoperatively.
Secondary outcomes (3)
Length of hospital stay
We evaluate the length of hospital stay, it was expressed in days as mean and standard deviation
Measured: From the day before the surgery up to 3 weeks after surgery. The number of days between hospital admission and discharge to home was calculated.
time to oral feeding resumption
Number of days between the surgery and the time the patient start to eat again by the mouth.
Measured: From the surgery up to two weeks.
incidence and onset of device-related complications
Incidence of immunologic reaction to the collagen matrix (tachosil). Expressed in number and pourcentage.
Measured: From the day of the surgery to one week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start16 Nov 2020
- Primary completion31 Oct 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity 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
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- SAYAH Charline
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SAYAH Charline, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337122
- Sponsor's protocol ID
- 2020/104
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Swallowing and Voice Outcomes After Collagen Matrix Reconstruction in Oral and Oropharyngeal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07337122
- Acronym / sponsor ID
- 2020/104
- Conditions
- Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharynx Squamous Cell Carcinoma, Oropharynx Cancer
- Keywords
- oral cancer, phonation, swallowing, voice, glossectomy, reconstruction, tachosil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- SAYAH CharlineUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 13 Jan 2026 (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.
This study tend to evaluate postoperative phonation and swallowing after oncologic surgery of the oral cavity or oropharynx with application of a collagen matrix (Tachosil®). Patients are asked to complete a questionnaire the day before the surgery and at 1 and 6 months after.
Detailed description
It was an interventional study with a single Group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –Patient were ≥18 years with a histologically confirmed squamous cell carcinoma or other malignant tumor of the oral cavity and/or oropharynx with surgical resection indicated (T1-T3). The performance status was betwen 0 and 2. Patients were receiving or not receiving postoperative adjuvant radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were selected among patients presenting to the ENT department of the University Hospital of Besançon for a suspected lesion of the oral cavity or oropharynx.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Histologically confirmed squamous cell carcinoma or other malignant tumor of the oral cavity and/or oropharynx
- Performance status (PS) 0-2
- Tumor stages for which surgical resection was indicated (T1-T3)
- Patients receiving or not receiving postoperative adjuvant radiotherapy
Key exclusion criteria (6 listed)
- Legal incapacity or limited legal capacity
- Inability or anticipated poor compliance with study procedures
- Missing questionnaire data
- Congenital or acquired swallowing disorders (neurological or neuromuscular disease)
- Congenital or acquired speech disorders (neurological or neuromuscular disease)
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
Swallowing evaluation
Time frame: From enrollment (the day before the surgery) to 6 months postoperatively.
We use the Deglutition Handicap Index questionnaire to evaluative swallowing before and after surgery. Patients completed the questionnaires the day before surgery, and at 1 month and 6 months postoperatively.
Voice evaluation
Time frame: From enrollment (the day before the surgery) to 6 months postoperatively.
We use the Voice Handicap Index questionnaire to evaluate the phonatione before and after surgery. Patients completed the questionnaires the day before surgery, and at 1 month and 6 months postoperatively.
3 secondary outcomes
Length of hospital stay
Time frame: From the day before the surgery up to 3 weeks after surgery. The number of days between hospital admission and discharge to home was calculated.
time to oral feeding resumption
Time frame: From the surgery up to two weeks.
incidence and onset of device-related complications
Time frame: From the day of the surgery to one week after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer and Oropharynx Squamous Cell Carcinoma, run by SAYAH Charline at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Swallowing evaluation (time frame: From enrollment (the day before the surgery) to 6 months postoperatively.). The study lists 2 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 13 Jan 2026.