Oral Cavity Squamous Cell CarcinomaNCT05950737
Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience
A study testing Sentinel node biopsy in people with Oral Cavity Squamous Cell Carcinoma, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Sentinel node biopsy is a suitable alternative to END and is recommended in standard guidelines. Investigators have been doing SNB in their department to standardize the process for the last two years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Sentinel node biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2021to 31 Jul 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 75 years of age,
- Biopsy-proven invasive squamous cell carcinoma involving site among tongue and buccal mucosa
- T1 and T2 lesions as per AJCC TNM classification
- Clinicoradiologically node negative
- Amenable to per oral excision
Who cannot join
- Upper alveolar or palatal lesions
- Large heterogeneous leukoplakia or other premalignant lesion
- T3/T4 lesions
- Lesions requiring raising of cheek flap to access for excision
Trial locations and contacts
1 site in 1 country.
About this study
Sentinel node biopsy is a suitable alternative to END and is recommended in standard guidelines. Investigators have been doing SNB in their department to standardize the process for the last two years. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at their institute.
Read the detailed description
Elective neck dissection (END) is the standard of care in node-negative early oral cancers.
However, it is associated with morbidity predominantly of shoulder dysfunction. Moreover, nearly 55-70% are true node-negative and are over-treated with this approach. Attempts have been made to overcome this limitation and to identify true node-negative patients. Sentinel node biopsy has shown the highest diagnostic accuracy among all other options. The SN is the first echelon node that drains directly through the lymphatics from the primary tumour. The principle of SNB is based on the fact that since it is the first echelon node, it would be the first site of regional metastasis. Therefore, the metastasis is unlikely to involve other nodal levels if the SNB is negative. It is the standard of care in breast cancers and melanoma. The concept made its way into oral cavity tumours and has been explored for over a decade in this setting. The results of the multi-institutional trial by Civantos et al. reported a high NPV of 94% of this procedure in early oral cancers that were node negative. Since then, various meta-analyses have shown that SNB has a high NPV making it a strong diagnostic modality. Schilling et al. reported the 3-year results of SNB in oral cancers in a multicentric study comprising 415 patients. The authors successfully identified the SN in 99.5% of cases and reported an FNR of 14%, which was high. Despite this, the study showed a high 3-year-disease-specific survival of 94%. Recently published Phase III Randomized controlled trials have shown that the overall survival of sentinel node biopsy is comparable to END with lesser morbidity in shoulder dysfunction. The advantage of the procedure is that only 25-30% of the patients who are SNB positive need to undergo neck dissection, and it spares unnecessary neck clearance and hence limits the morbidity in the remaining 70-75% of cases. SNB is a suitable alternative to END and is recommended in standard guidelines. However, SNB has a learning curve, it is recommended that the process be standardized, and the team should perform adequate SNB, followed by the completion of neck dissection before sparing the neck based on SNB. Investigators have been doing SNB in their department to standardize the process following the publication of level I evidence. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at the investigator's institute.
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Being tested
- Sentinel node biopsy
- Keywords
- oral neoplasm, sentinel node biopsy, node negative
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node biopsyProcedure or surgery
All patients have undergone completion neck dissection following SNB in the process of standardization.
| Study group | Role | What they receive |
|---|---|---|
| sentinel node biopsy | Experimental | All patients have undergone completion neck dissection following SNB in the process of standardization. The SNB was localized by peritumoral infiltration of the nano colloid, followed by dynamic planar imaging for 30 minutes, and then SPECT was performed. The surgery was performed on the same day within 6 hours of localisation, and intraoperatively, either methylene blue or indocyanine green was used as an adjunct. Appropriately labelled sentinel nodes were assessed on the frozen section, which was then sectioned into 2-3mm slices perpendicular to the longest axis of the node and submitted entirely for microscopic evaluation. A minimum of 2 sections were evaluated, one stained with Toluidine blue and the other with rapid Haematoxylin and Eosin (HE) stain. The nodes were subsequently subjected to histopathological processing. Receives: Procedure: Sentinel node biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the SNB
Sensitivity, specificity, negative predictive value, positive predictive value, False negative rate, SNB identification rate
Measured: Through study completion, an average of 2 year
Secondary outcomes (1)
To study the pattern of metastasis in sentinel and non-sentinel nodes
Level-wise frequency of SN metastasis, Frequency of metastasis in the SN basin, Frequency of metastasis to extra sentinel nodal basin
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jun 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Oral Cavity Squamous Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Richa Vaish, Tata Memorial Hospital
- Investigators
- Richa Vaish, MS. M.Ch, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950737
- Sponsor's protocol ID
- 4205
- Status last verified
- Oct 2024
- First submitted
- 7 Jul 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaish R, Hawaldar R, Gupta S, Dandekar M, Shah S, Chaukar D, Pantvaidya G, Deshmukh A, Chaturvedi P, Pai P, Nair D, Nair S, Thakur M, Ghosh-Laskar S, Agarwal JP, D'Cruz AK. N0 neck trial: Does intensification of follow-up (Ultrasound + Physical Examination) influence outcomes in early-stage oral cancer? Eur J Cancer. 2024 Jun;204:114064. doi: 10.1016/j.ejca.2024.114064. Epub 2024 Apr 16.
PubMed 38705028D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
PubMed 26027881Civantos FJ, Zitsch RP, Schuller DE, Agrawal A, Smith RB, Nason R, Petruzelli G, Gourin CG, Wong RJ, Ferris RL, El Naggar A, Ridge JA, Paniello RC, Owzar K, McCall L, Chepeha DB, Yarbrough WG, Myers JN. Sentinel lymph node biopsy accurately stages the regional lymph nodes for T1-T2 oral squamous cell carcinomas: results of a prospective multi-institutional trial. J Clin Oncol. 2010 Mar 10;28(8):1395-400. doi: 10.1200/JCO.2008.20.8777. Epub 2010 Feb 8.
PubMed 20142602Thompson CF, St John MA, Lawson G, Grogan T, Elashoff D, Mendelsohn AH. Diagnostic value of sentinel lymph node biopsy in head and neck cancer: a meta-analysis. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2115-22. doi: 10.1007/s00405-012-2320-0. Epub 2012 Dec 22.
PubMed 23263205Mallo Magarinos M, Suarez Ajuria M, Marichalar Mendia X, Alvarez-Calderon Iglesias O, Chamorro Petronacci CM, Garcia Garcia A, Perez Sayans M. Diagnostic yield of sentinel lymph node biopsy in oral squamous cell carcinoma T1/T2-N0: systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2021 Oct;50(10):1271-1279. doi: 10.1016/j.ijom.2021.01.020. Epub 2021 Feb 16.
PubMed 33602650Yang Y, Zhou J, Wu H. Diagnostic value of sentinel lymph node biopsy for cT1/T2N0 tongue squamous cell carcinoma: a meta-analysis. Eur Arch Otorhinolaryngol. 2017 Nov;274(11):3843-3852. doi: 10.1007/s00405-017-4740-3. Epub 2017 Sep 12.
PubMed 28900723Schilling C, Stoeckli SJ, Haerle SK, Broglie MA, Huber GF, Sorensen JA, Bakholdt V, Krogdahl A, von Buchwald C, Bilde A, Sebbesen LR, Odell E, Gurney B, O'Doherty M, de Bree R, Bloemena E, Flach GB, Villarreal PM, Fresno Forcelledo MF, Junquera Gutierrez LM, Amezaga JA, Barbier L, Santamaria-Zuazua J, Moreira A, Jacome M, Vigili MG, Rahimi S, Tartaglione G, Lawson G, Nollevaux MC, Grandi C, Donner D, Bragantini E, Dequanter D, Lothaire P, Poli T, Silini EM, Sesenna E, Dolivet G, Mastronicola R, Leroux A, Sassoon I, Sloan P, McGurk M. Sentinel European Node Trial (SENT): 3-year results of sentinel node biopsy in oral cancer. Eur J Cancer. 2015 Dec;51(18):2777-84. doi: 10.1016/j.ejca.2015.08.023. Epub 2015 Nov 18.
PubMed 26597442Garrel R, Poissonnet G, Moya Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.
PubMed 33052754Hasegawa Y, Tsukahara K, Yoshimoto S, Miura K, Yokoyama J, Hirano S, Uemura H, Sugasawa M, Yoshizaki T, Homma A, Chikamatsu K, Suzuki M, Shiotani A, Matsuzuka T, Kohno N, Miyazaki M, Oze I, Matsuo K, Kosuda S, Yatabe Y; HNCMM Research Group. Neck Dissections Based on Sentinel Lymph Node Navigation Versus Elective Neck Dissections in Early Oral Cancers: A Randomized, Multicenter, and Noninferiority Trial. J Clin Oncol. 2021 Jun 20;39(18):2025-2036. doi: 10.1200/JCO.20.03637. Epub 2021 Apr 20.
PubMed 33877855Vaish R, Mittal N, Mahajan A, Rane SU, Agrawal A, D'Cruz AK. Sentinel node biopsy in node negative early oral cancers: Solution to the conundrum! Oral Oncol. 2022 Nov;134:106070. doi: 10.1016/j.oraloncology.2022.106070. Epub 2022 Aug 18.
PubMed 35988294Vaish R. Shifting Paradigm of the Management of Node-Negative Neck in Early Oral Cancers: Where do we Stand Today? Indian J Med Paediatr Oncol 2022; 43(01): 092-094 DOI: 10.1055/s-0042-1742637
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience
- ClinicalTrials.gov ID
- NCT05950737
- Acronym / sponsor ID
- 4205
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Keywords
- oral neoplasm, sentinel node biopsy, node negative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 18 Jul 2023 (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.
Sentinel node biopsy is a suitable alternative to END and is recommended in standard guidelines. Investigators have been doing SNB in their department to standardize the process for the last two years. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at their institute.
Detailed description
Elective neck dissection (END) is the standard of care in node-negative early oral cancers.
However, it is associated with morbidity predominantly of shoulder dysfunction. Moreover, nearly 55-70% are true node-negative and are over-treated with this approach. Attempts have been made to overcome this limitation and to identify true node-negative patients. Sentinel node biopsy has shown the highest diagnostic accuracy among all other options. The SN is the first echelon node that drains directly through the lymphatics from the primary tumour. The principle of SNB is based on the fact that since it is the first echelon node, it would be the first site of regional metastasis. Therefore, the metastasis is unlikely to involve other nodal levels if the SNB is negative. It is the standard of care in breast cancers and melanoma. The concept made its way into oral cavity tumours and has been explored for over a decade in this setting. The results of the multi-institutional trial by Civantos et al. reported a high NPV of 94% of this procedure in early oral cancers that were node negative. Since then, various meta-analyses have shown that SNB has a high NPV making it a strong diagnostic modality. Schilling et al. reported the 3-year results of SNB in oral cancers in a multicentric study comprising 415 patients. The authors successfully identified the SN in 99.5% of cases and reported an FNR of 14%, which was high. Despite this, the study showed a high 3-year-disease-specific survival of 94%. Recently published Phase III Randomized controlled trials have shown that the overall survival of sentinel node biopsy is comparable to END with lesser morbidity in shoulder dysfunction. The advantage of the procedure is that only 25-30% of the patients who are SNB positive need to undergo neck dissection, and it spares unnecessary neck clearance and hence limits the morbidity in the remaining 70-75% of cases. SNB is a suitable alternative to END and is recommended in standard guidelines. However, SNB has a learning curve, it is recommended that the process be standardized, and the team should perform adequate SNB, followed by the completion of neck dissection before sparing the neck based on SNB. Investigators have been doing SNB in their department to standardize the process following the publication of level I evidence. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at the investigator's institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sentinel node biopsy | Experimental | Procedure: Sentinel node biopsyAll patients have undergone completion neck dissection following SNB in the process of standardization. The SNB was localized by peritumoral infiltration of the nano colloid, followed by dynamic planar imaging for 30 minutes, and then SPECT was performed. The surgery was performed on the same day within 6 hours of localisation, and intraoperatively, either methylene blue or indocyanine green was used as an adjunct. Appropriately labelled sentinel nodes were assessed on the frozen section, which was then sectioned into 2-3mm slices perpendicular to the longest axis of the node and submitted entirely for microscopic evaluation. A minimum of 2 sections were evaluated, one stained with Toluidine blue and the other with rapid Haematoxylin and Eosin (HE) stain. The nodes were subsequently subjected to histopathological processing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 to 75 years of age,
- Biopsy-proven invasive squamous cell carcinoma involving site among tongue and buccal mucosa
- T1 and T2 lesions as per AJCC TNM classification
- Clinicoradiologically node negative
- Amenable to per oral excision
Key exclusion criteria (4 listed)
- Upper alveolar or palatal lesions
- Large heterogeneous leukoplakia or other premalignant lesion
- T3/T4 lesions
- Lesions requiring raising of cheek flap to access for excision
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 |
|---|---|---|
| Sentinel node biopsyAll patients have undergone completion neck dissection following SNB in the process of standardization. | Procedure or surgery | sentinel node biopsy |
Primary outcome
Diagnostic accuracy of the SNB
Time frame: Through study completion, an average of 2 year
Sensitivity, specificity, negative predictive value, positive predictive value, False negative rate, SNB identification rate
1 secondary outcome
To study the pattern of metastasis in sentinel and non-sentinel nodes
Time frame: Through study completion, an average of 2 year
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 30 Oct 2024.
- Background: PubMed 38705028Vaish R, Hawaldar R, Gupta S, Dandekar M, Shah S, Chaukar D, Pantvaidya G, Deshmukh A, Chaturvedi P, Pai P, Nair D, Nair S, Thakur M, Ghosh-Laskar S, Agarwal JP, D'Cruz AK. N0 neck trial: Does intensification of follow-up (Ultrasound + Physical Examination) influence outcomes in early-stage oral cancer? Eur J Cancer. 2024 Jun;204:114064. doi: 10.1016/j.ejca.2024.114064. Epub 2024 Apr 16.
- Background: PubMed 26027881D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
- Background: PubMed 20142602Civantos FJ, Zitsch RP, Schuller DE, Agrawal A, Smith RB, Nason R, Petruzelli G, Gourin CG, Wong RJ, Ferris RL, El Naggar A, Ridge JA, Paniello RC, Owzar K, McCall L, Chepeha DB, Yarbrough WG, Myers JN. Sentinel lymph node biopsy accurately stages the regional lymph nodes for T1-T2 oral squamous cell carcinomas: results of a prospective multi-institutional trial. J Clin Oncol. 2010 Mar 10;28(8):1395-400. doi: 10.1200/JCO.2008.20.8777. Epub 2010 Feb 8.
- Background: PubMed 23263205Thompson CF, St John MA, Lawson G, Grogan T, Elashoff D, Mendelsohn AH. Diagnostic value of sentinel lymph node biopsy in head and neck cancer: a meta-analysis. Eur Arch Otorhinolaryngol. 2013 Jul;270(7):2115-22. doi: 10.1007/s00405-012-2320-0. Epub 2012 Dec 22.
- Background: PubMed 33602650Mallo Magarinos M, Suarez Ajuria M, Marichalar Mendia X, Alvarez-Calderon Iglesias O, Chamorro Petronacci CM, Garcia Garcia A, Perez Sayans M. Diagnostic yield of sentinel lymph node biopsy in oral squamous cell carcinoma T1/T2-N0: systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2021 Oct;50(10):1271-1279. doi: 10.1016/j.ijom.2021.01.020. Epub 2021 Feb 16.
- Background: PubMed 28900723Yang Y, Zhou J, Wu H. Diagnostic value of sentinel lymph node biopsy for cT1/T2N0 tongue squamous cell carcinoma: a meta-analysis. Eur Arch Otorhinolaryngol. 2017 Nov;274(11):3843-3852. doi: 10.1007/s00405-017-4740-3. Epub 2017 Sep 12.
- Background: PubMed 26597442Schilling C, Stoeckli SJ, Haerle SK, Broglie MA, Huber GF, Sorensen JA, Bakholdt V, Krogdahl A, von Buchwald C, Bilde A, Sebbesen LR, Odell E, Gurney B, O'Doherty M, de Bree R, Bloemena E, Flach GB, Villarreal PM, Fresno Forcelledo MF, Junquera Gutierrez LM, Amezaga JA, Barbier L, Santamaria-Zuazua J, Moreira A, Jacome M, Vigili MG, Rahimi S, Tartaglione G, Lawson G, Nollevaux MC, Grandi C, Donner D, Bragantini E, Dequanter D, Lothaire P, Poli T, Silini EM, Sesenna E, Dolivet G, Mastronicola R, Leroux A, Sassoon I, Sloan P, McGurk M. Sentinel European Node Trial (SENT): 3-year results of sentinel node biopsy in oral cancer. Eur J Cancer. 2015 Dec;51(18):2777-84. doi: 10.1016/j.ejca.2015.08.023. Epub 2015 Nov 18.
- Background: PubMed 33052754Garrel R, Poissonnet G, Moya Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.
- Background: PubMed 33877855Hasegawa Y, Tsukahara K, Yoshimoto S, Miura K, Yokoyama J, Hirano S, Uemura H, Sugasawa M, Yoshizaki T, Homma A, Chikamatsu K, Suzuki M, Shiotani A, Matsuzuka T, Kohno N, Miyazaki M, Oze I, Matsuo K, Kosuda S, Yatabe Y; HNCMM Research Group. Neck Dissections Based on Sentinel Lymph Node Navigation Versus Elective Neck Dissections in Early Oral Cancers: A Randomized, Multicenter, and Noninferiority Trial. J Clin Oncol. 2021 Jun 20;39(18):2025-2036. doi: 10.1200/JCO.20.03637. Epub 2021 Apr 20.
- Background: PubMed 35988294Vaish R, Mittal N, Mahajan A, Rane SU, Agrawal A, D'Cruz AK. Sentinel node biopsy in node negative early oral cancers: Solution to the conundrum! Oral Oncol. 2022 Nov;134:106070. doi: 10.1016/j.oraloncology.2022.106070. Epub 2022 Aug 18.
- BackgroundVaish R. Shifting Paradigm of the Management of Node-Negative Neck in Early Oral Cancers: Where do we Stand Today? Indian J Med Paediatr Oncol 2022; 43(01): 092-094 DOI: 10.1055/s-0042-1742637
- Individual participant dataSharing planned: No
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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.
Richa Vaish, MS. M.Ch principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel node biopsy in people with Oral Cavity Squamous Cell Carcinoma, run by Tata Memorial Hospital at 1 site in India.
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 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: finished, as of the sponsor's last update on 30 Oct 2024. 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 India. 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?
Diagnostic accuracy of the SNB (time frame: Through study completion, an average of 2 year). 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 NCT05950737, which also lists 11 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 30 Oct 2024.