CancerNCT03837613
Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis.
An observational study of Cancer and Squamous Cell Carcinoma, run by Mohamed Ghorab at 1 site in Egypt.
Trial summary
Does the tumor thickness value of buccal squamous cell carcinomas, predict cervical nodal metastasis in clinically and radio-graphical neck negative (N0) thus sparing such patients unnecessary surgical procedures and it's associated morbidities? The aim of the study is to evaluate the prognostic value of tumor… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Squamous Cell Carcinoma
- What is being tested?
- tumor resection and neck dissection
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2019to Dec 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Egyptians Patients presenting to Cairo University dental Hospital, National Cancer Institute, and Al Monofia university hospital who fits the eligibility criteria.
Who may be able to join
- Egyptian patients with BSCC (T all N0) not previously operated or treated with adjunctive therapy. They should present with no clinical signs of neck lymph nodes involvement.
Who cannot join
- Patients with lesions secondary to another primary site.
- Patients previously removed a primary oral surgery tumor in another site
- Patients with clinical or radiographic evidence of cervical nodal metastases
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University - Faculty of Oral and Dental Medicine
Cairo, 12111
Mohamed Ghorab, BDS, 01002841441, ddsmghorab@gmail.com
About this study
Official title: Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis in the Neck: A Cohort Study
Does the tumor thickness value of buccal squamous cell carcinomas, predict cervical nodal metastasis in clinically and radio-graphical neck negative (N0) thus sparing such patients unnecessary surgical procedures and it's associated morbidities? The aim of the study is to evaluate the prognostic value of tumor thickness cut off 4 mm in predicting cervical nodal metastases in a population of Egyptian patients presenting with Buccal Squamous Cell Carcinoma. The hypothesis is that patients with tumor thickness less than 4 mm will present with significantly less cervical nodal metastasis.
Read the detailed description
Patients will be recruited from the outpatient clinics of Al Monofia university hospital, Cairo University Hospital and National Cancer Institute. Patients who fits the inclusion criteria and are motivated and consent to enter the study will be included. Patient recruitment will continue until the target sample size is reached.
Patients data will be collected including personal data, medical history, family history, and classification of the tumor according to the TNM classification system. Patients will be assessed preoperatively with a transcutaneous high frequency probe ultrasound to measure the maximal tumor thickness in millimeters using a 10MHz superficial probe and the lymph nodes in the neck region. In addition to clinical examination and palpation of the neck lymph nodes. Patients will then undergo tumor resection surgery with adequate safety margins under GA with nasotracheal intubation. Selective neck dissection will then be performed. The specimens will be submitted for histopathological examination.
Patients will receive standard post operative care based on the recommendation of the oncologist. Adjunct chemo or radiotherapy will be administered when deemed necessary. Wound care and dressings will be administered as needed.
Patients will be categorized into two groups based on the tumor thickness (exposure).
For the primary outcome, the data source will be the measurement of tumor depth based on Berslow method as discussed in the review of literature, obtained from ultrasonography and recorded in millimeters.Tumor width recorded in (mm) will also be obtained from the ultrasonography as it may be a source of confounders. Further, histological grade of the lesion will also be recorded.
Two confounding factors are highlighted and may be sources of bias and attempt to control for them in the statistical analyses will be made.
Appropriate statistical methods will be used after collection of the data and sources of confounders will be controlled for during analyses in subgroup An attempt to control for tumor width and histological grade in subgroup analyses
All data will be entered electronically. Patients' files are to be stored in numerical order and stored in secure and accessible place. All data will be maintained in storage for 1 year after completion of the study. Data monitoring committee is independent from the sponsor and competing interest.
- Conditions
- Cancer, Squamous Cell Carcinoma
- Being tested
- tumor resection and neck dissection
- Keywords
- cancer, squamous cell carcinoma, ultrasound, tumor thickness
- Medical subject headings
- Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor resection and neck dissectionProcedure or surgery
Surgical removal of the tumor with adequate safety margins. In addition to neck dissection to dissect the cervical lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (TT<4mm) | Patients with a preoperative tumor thickness less than 4 mm. Intervention: tumor resection and neck dissection Receives: Procedure: tumor resection and neck dissection | |
| Group 2 (TT >= 4mm) | Patients with a preoperative tumor thickness equal to or more than 4 mm Intervention: tumor resection and neck dissection Receives: Procedure: tumor resection and neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical nodal metastasis
Number of patients with positive cervical nodal metastasis
Measured: one week after the surgery
Secondary outcomes (1)
Tumor thickness
Correlation between the tumor thickness measured preoperatively by ultrasound versus the tumor thickness measured from the histopathological specimen
Measured: one week after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study startFeb 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Ghorab
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Mohamed Ghorab, Cairo University
- Investigators
- Mohamed Ghorab, BSD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837613
- Sponsor's protocol ID
- MohamedGhorabMSc
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang SH, Hwang D, Lockwood G, Goldstein DP, O'Sullivan B. Predictive value of tumor thickness for cervical lymph-node involvement in squamous cell carcinoma of the oral cavity: a meta-analysis of reported studies. Cancer. 2009 Apr 1;115(7):1489-97. doi: 10.1002/cncr.24161.
PubMed 19197973Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20.
PubMed 19026588Deshpande G, Das S. Tumor Thickness: A predictor of nodal disease in early squamous cell carcinomas of buccal mucosa. Gulf J Oncolog. 2015 May;1(18):37-43.
PubMed 26003104
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis in the Neck: A Cohort Study
- ClinicalTrials.gov ID
- NCT03837613
- Acronym / sponsor ID
- MohamedGhorabMSc
- Conditions
- Cancer, Squamous Cell Carcinoma
- Keywords
- cancer, squamous cell carcinoma, ultrasound, tumor thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mohamed GhorabUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Feb 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Feb 2019 (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.
Does the tumor thickness value of buccal squamous cell carcinomas, predict cervical nodal metastasis in clinically and radio-graphical neck negative (N0) thus sparing such patients unnecessary surgical procedures and it's associated morbidities? The aim of the study is to evaluate the prognostic value of tumor thickness cut off 4 mm in predicting cervical nodal metastases in a population of Egyptian patients presenting with Buccal Squamous Cell Carcinoma. The hypothesis is that patients with tumor thickness less than 4 mm will present with significantly less cervical nodal metastasis.
Detailed description
Patients will be recruited from the outpatient clinics of Al Monofia university hospital, Cairo University Hospital and National Cancer Institute. Patients who fits the inclusion criteria and are motivated and consent to enter the study will be included. Patient recruitment will continue until the target sample size is reached.
Patients data will be collected including personal data, medical history, family history, and classification of the tumor according to the TNM classification system. Patients will be assessed preoperatively with a transcutaneous high frequency probe ultrasound to measure the maximal tumor thickness in millimeters using a 10MHz superficial probe and the lymph nodes in the neck region. In addition to clinical examination and palpation of the neck lymph nodes. Patients will then undergo tumor resection surgery with adequate safety margins under GA with nasotracheal intubation. Selective neck dissection will then be performed. The specimens will be submitted for histopathological examination.
Patients will receive standard post operative care based on the recommendation of the oncologist. Adjunct chemo or radiotherapy will be administered when deemed necessary. Wound care and dressings will be administered as needed.
Patients will be categorized into two groups based on the tumor thickness (exposure).
For the primary outcome, the data source will be the measurement of tumor depth based on Berslow method as discussed in the review of literature, obtained from ultrasonography and recorded in millimeters.Tumor width recorded in (mm) will also be obtained from the ultrasonography as it may be a source of confounders. Further, histological grade of the lesion will also be recorded.
Two confounding factors are highlighted and may be sources of bias and attempt to control for them in the statistical analyses will be made.
Appropriate statistical methods will be used after collection of the data and sources of confounders will be controlled for during analyses in subgroup An attempt to control for tumor width and histological grade in subgroup analyses
All data will be entered electronically. Patients' files are to be stored in numerical order and stored in secure and accessible place. All data will be maintained in storage for 1 year after completion of the study. Data monitoring committee is independent from the sponsor and competing interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (TT<4mm) | – | Procedure: tumor resection and neck dissectionPatients with a preoperative tumor thickness less than 4 mm. Intervention: tumor resection and neck dissection |
| Group 2 (TT >= 4mm) | – | Procedure: tumor resection and neck dissectionPatients with a preoperative tumor thickness equal to or more than 4 mm Intervention: tumor resection and neck dissection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Egyptians Patients presenting to Cairo University dental Hospital, National Cancer Institute, and Al Monofia university hospital who fits the eligibility criteria.
Key inclusion criteria (1 listed)
- Egyptian patients with BSCC (T all N0) not previously operated or treated with adjunctive therapy. They should present with no clinical signs of neck lymph nodes involvement.
Key exclusion criteria (3 listed)
- Patients with lesions secondary to another primary site.
- Patients previously removed a primary oral surgery tumor in another site
- Patients with clinical or radiographic evidence of cervical nodal metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tumor resection and neck dissectionSurgical removal of the tumor with adequate safety margins. In addition to neck dissection to dissect the cervical lymph nodes. | Procedure or surgery | Group 1 (TT<4mm), Group 2 (TT >= 4mm) |
Primary outcome
Cervical nodal metastasis
Time frame: one week after the surgery
Number of patients with positive cervical nodal metastasis
1 secondary outcome
Tumor thickness
Time frame: one week after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Background: PubMed 19197973Huang SH, Hwang D, Lockwood G, Goldstein DP, O'Sullivan B. Predictive value of tumor thickness for cervical lymph-node involvement in squamous cell carcinoma of the oral cavity: a meta-analysis of reported studies. Cancer. 2009 Apr 1;115(7):1489-97. doi: 10.1002/cncr.24161.
- Background: PubMed 19026588Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20.
- Background: PubMed 26003104Deshpande G, Das S. Tumor Thickness: A predictor of nodal disease in early squamous cell carcinomas of buccal mucosa. Gulf J Oncolog. 2015 May;1(18):37-43.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Mohamed Ghorab, BSD principal investigator
Cairo University
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 Cancer and Squamous Cell Carcinoma, run by Mohamed Ghorab at 1 site in Egypt.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. 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 Egypt. 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?
Contact Mohamed Ghorab, BDS (01002841441, ddsmghorab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical nodal metastasis (time frame: one week after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03837613, which also lists 3 linked publications.
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 12 Feb 2019.