Surveillance of Regional Nodal Basins in Patients With Primary High Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck

Cutaneous Squamous Cell Carcinoma of the Head and Neck Clinical Trial

Official title:

Surveillance of Regional Nodal Basins in Patients With Primary High Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956795
• Other study ID #: IRB00270545
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Kristin Bibee, MD
• Phone: 410-955-1588
• Email: kbibee1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this prospective cohort study, investigators will conduct ultrasound surveillance of the nodal basins of patients with head and neck cutaneous squamous cell carcinoma (cSCC) whose tumors are considered high risk and staged by the Brigham and Women's Hospital (BWH) tumor staging system. The study will enroll patients with tumors staged T2a and who are also immunosuppressed (from solid organ transplant, hematologic malignancy or autoimmune disease), T2b (sentinel lymph node negative), and T3 (sentinel lymph node negative). After two years of surveillance, outcomes regarding local recurrence, nodal metastasis, disease specific death, and overall survival will be compared with historical controls with the overall hypothesis that ultrasound surveillance will detect subclinical disease earlier and help improve outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: December 31, 2028
• Est. primary completion date: August 14, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All cSCC must be on the head or neck

• All cSCC must be primary tumors.

• BWH stage T2a tumors in patients who are on chronic immunosuppression (organ transplant, hematologic malignancy, autoimmune disease)

• All BWH T2b or T3 tumors with a negative CT of the nodal basin AND a negative SLNB

Exclusion Criteria:

• Recurrent tumors

• Patients who are BWH T2b/T3 who have a positive CT of the nodal basin or positive lymph node biopsy

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Squamous Cell Carcinoma of Head and Neck

Intervention

Diagnostic Test:
• Ultrasound
Sonographic imaging will be performed of lymph node basins

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (16)

Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17. — View Citation

Bander TS, Nehal KS, Lee EH. Cutaneous Squamous Cell Carcinoma: Updates in Staging and Management. Dermatol Clin. 2019 Jul;37(3):241-251. doi: 10.1016/j.det.2019.03.009. — View Citation

de Bondt RB, Nelemans PJ, Hofman PA, Casselman JW, Kremer B, van Engelshoven JM, Beets-Tan RG. Detection of lymph node metastases in head and neck cancer: a meta-analysis comparing US, USgFNAC, CT and MR imaging. Eur J Radiol. 2007 Nov;64(2):266-72. doi: 10.1016/j.ejrad.2007.02.037. Epub 2007 Mar 27. — View Citation

Farasat S, Yu SS, Neel VA, Nehal KS, Lardaro T, Mihm MC, Byrd DR, Balch CM, Califano JA, Chuang AY, Sharfman WH, Shah JP, Nghiem P, Otley CC, Tufaro AP, Johnson TM, Sober AJ, Liegeois NJ. A new American Joint Committee on Cancer staging system for cutaneous squamous cell carcinoma: creation and rationale for inclusion of tumor (T) characteristics. J Am Acad Dermatol. 2011 Jun;64(6):1051-9. doi: 10.1016/j.jaad.2010.08.033. Epub 2011 Jan 20. — View Citation

Fox M, Brown M, Golda N, Goldberg D, Miller C, Pugliano-Mauro M, Schmults C, Shin T, Stasko T, Xu YG, Nehal K; High Risk Squamous Cell Carcinoma Workgroup; Dermatologic Surgery Section of the Association of Professors of Dermatology. Nodal staging of high-risk cutaneous squamous cell carcinoma. J Am Acad Dermatol. 2019 Aug;81(2):548-557. doi: 10.1016/j.jaad.2018.09.006. Epub 2018 Sep 15. — View Citation

Jambusaria-Pahlajani A, Kanetsky PA, Karia PS, Hwang WT, Gelfand JM, Whalen FM, Elenitsas R, Xu X, Schmults CD. Evaluation of AJCC tumor staging for cutaneous squamous cell carcinoma and a proposed alternative tumor staging system. JAMA Dermatol. 2013 Apr;149(4):402-10. doi: 10.1001/jamadermatol.2013.2456. — View Citation

Karia PS, Han J, Schmults CD. Cutaneous squamous cell carcinoma: estimated incidence of disease, nodal metastasis, and deaths from disease in the United States, 2012. J Am Acad Dermatol. 2013 Jun;68(6):957-66. doi: 10.1016/j.jaad.2012.11.037. Epub 2013 Feb 1. — View Citation

Lukowiak TM, Aizman L, Perz A, Miller CJ, Sobanko JF, Shin TM, Giordano CN, Higgins HW 2nd, Etzkorn JR. Association of Age, Sex, Race, and Geographic Region With Variation of the Ratio of Basal Cell to Cutaneous Squamous Cell Carcinomas in the United States. JAMA Dermatol. 2020 Nov 1;156(11):1192-1198. doi: 10.1001/jamadermatol.2020.2571. — View Citation

Maher JM, Schmults CD, Murad F, Karia PS, Benson CB, Ruiz ES. Detection of subclinical disease with baseline and surveillance imaging in high-risk cutaneous squamous cell carcinomas. J Am Acad Dermatol. 2020 Apr;82(4):920-926. doi: 10.1016/j.jaad.2019.10.067. Epub 2019 Nov 2. — View Citation

Navarrete-Dechent C, Veness MJ, Droppelmann N, Uribe P. High-risk cutaneous squamous cell carcinoma and the emerging role of sentinel lymph node biopsy: A literature review. J Am Acad Dermatol. 2015 Jul;73(1):127-37. doi: 10.1016/j.jaad.2015.03.039. — View Citation

Pampena R, Raucci M, Mirra M, Lombardi M, Piana S, Kyrgidis A, Peccerillo F, Paganelli A, Garbarino F, Pellacani G, Longo C. The role of ultrasound examination for early identification of lymph-node metastasis of cutaneous squamous cell carcinoma: results from a single institutional center. Ital J Dermatol Venerol. 2021 Aug;156(4):479-483. doi: 10.23736/S2784-8671.19.06487-3. Epub 2019 Dec 4. — View Citation

Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: Incidence, risk factors, diagnosis, and staging. J Am Acad Dermatol. 2018 Feb;78(2):237-247. doi: 10.1016/j.jaad.2017.08.059. — View Citation

Que SKT, Zwald FO, Schmults CD. Cutaneous squamous cell carcinoma: Management of advanced and high-stage tumors. J Am Acad Dermatol. 2018 Feb;78(2):249-261. doi: 10.1016/j.jaad.2017.08.058. — View Citation

Ruiz ES, Karia PS, Besaw R, Schmults CD. Performance of the American Joint Committee on Cancer Staging Manual, 8th Edition vs the Brigham and Women's Hospital Tumor Classification System for Cutaneous Squamous Cell Carcinoma. JAMA Dermatol. 2019 Jul 1;155(7):819-825. doi: 10.1001/jamadermatol.2019.0032. — View Citation

Ruiz ES, Karia PS, Morgan FC, Schmults CD. The positive impact of radiologic imaging on high-stage cutaneous squamous cell carcinoma management. J Am Acad Dermatol. 2017 Feb;76(2):217-225. doi: 10.1016/j.jaad.2016.08.051. Epub 2016 Oct 1. — View Citation

Tejera-Vaquerizo A, Canueto J, Llombart B, Martorell-Calatayud A, Sanmartin O. Predictive Value of Sentinel Lymph Node Biopsy in Cutaneous Squamous Cell Carcinoma Based on the AJCC-8 and Brigham and Women's Hospital Staging Criteria. Dermatol Surg. 2020 Jul;46(7):857-862. doi: 10.1097/DSS.0000000000002170. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Nodal metastasis	Metastatic squamous cell carcinoma to lymph node basins will be assessed through regular US surveillance of each cohort group along with review of respective medical records for any subsequent studies that were performed to confirm metastasis during routine care. Review of medical records will be conducted for historical controls.; Investigators will then compare time to nodal metastasis between the US surveillance group and the historical controls using Kaplan-Meier estimates of the survivor function and a log-rank test. The investigators will also use Cox proportional-hazards regression to estimate the hazard ratio of nodal metastasis between these two group while adjusting for the covariates of age, sex, stage, etc.	From diagnosis up to 2 years
Secondary	Number of participants with local recurrence of squamous cell carcinoma	Recurrent squamous cell carcinoma in the original excision site will be confirmed by review of respective medical records/charts for subsequent confirmation studies performed during routine care.; Investigators will use Kaplan-Meier estimates, a log-rank test, and Cox proportional-hazards to compare time to local recurrence between groups	From diagnosis up to 2 years
Secondary	Disease specific death	Death from cutaneous squamous cell carcinoma will be determined by review of medical records.; Investigators will compare two-year disease-specific mortality rates between groups using a test of two proportions followed by logistic regression to allow adjustment for covariates.	From diagnosis up to 2 years
Secondary	Overall survival rate	The percentage of participants in each cohort who are still alive at the end of the study.; Investigators will compare two-year overall mortality rates between groups using a test of two proportions followed by logistic regression to allow adjustment for covariates	From diagnosis up to 2 years