ctDNA in Cutaneous Squamous Cell Carcinoma

ConditionCutaneous Squamous Cell Carcinoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMassachusetts Eye and Ear Infirmary

About this trial

The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with surgically resectable primary CSCC with PNI (>0.1mm caliber nerve) or at least 2 high-risk features defined as size > 2cm, recurrent CSCC, LVI, immunosuppressed, poorly differentiated, and/or invasion >6mm/beyond subcutaneous fat;

Patients with surgically resectable regional metastases not receiving neoadjuvant therapy

Disqualifiers

Patients with Cutaneous Squamous Cell Carcinoma not amenable to surgical resection

Patients receiving or undergoing systemic therapies.

Patients with resectable AJCC (8th ed) Stage II, III or IV(M0) CSCC treated with neoadjuvant immunotherapy as part of standard care.

Patients ineligible for neoadjuvant treatment.

Trial population

Patients ages 18 and older, who have been diagnosed with cutaneous squamous cell carcinoma (CSCC)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Blood and Tissue Collection
Diagnostic test
Blood samples, and tissue samples will be collected from the participants, and used to determine whether circulating tumor DNA (ctDNA) testing can help monitor treatment in patients with CSCC, and to determine how ctDNA levels change in patients.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: Post-Operative Cohort1 intervention

Group B: Neoadjuvant Cohort1 intervention

Group C: Definitive Immunotherapy Cohort1 intervention

Trial outcomes

Primary outcomes

2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery

To determine if there is an association between ctDNA clearance (defined as no detection of ctDNA) after surgical intervention and 2-year recurrence-free survival (RFS). The outcome will measure both ctDNA clearance (as a binary variable: detection or no detection) and RFS (measured in months). The association between these two outcomes will be analyzed as the primary outcome to determine if no detection of ctDNA is associated with longer RFS.

Time frame

24 Months

Neoadjuvant Cohort Primary Outcome: Response Monitoring

To evaluate ctDNA as a biomarker of response to neoadjuvant immunotherapy.

Time frame

24 Months

Definitive Treatment Cohort Primary Outcome

To evaluate whether ctDNA correlates with response to immunotherapy.

Time frame

24 Months

Secondary outcomes

Post-Operative Cohort Secondary Outcome: Residual Free Survival (RFS) Surveillance over 2 Year

To evaluate RFS during the surveillance period, stratified by ctDNA test status over time to determine if ctDNA levels predict recurrence

Time frame

24 Months

Neoadjuvant Cohort Secondary Outcome: Correlation with Pathological Response

To evaluate if ctDNA correlates with pathological response to neoadjuvant therapy. This will help determine if ctDNA may one day be used to help risk stratify which patients need surgery after neoadjuvant immunotherapy.

Time frame

24 Months

Other outcomes

Exploratory Outcome

To evaluate the time to ctDNA clearance (defined as the time from surgical intervention to the point where ctDNA is no longer detected, if ever) in the postoperative period, defined as months since surgery.

Time frame

24 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Eye and Ear Infirmary

Lead sponsor

Haystack Oncology, Inc.

Collaborator

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov

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