ctDNA for Early Detection of Recurrence in Melanoma

Melanoma Clinical Trial

Official title:

The Value of Circulating Tumour DNA in Early Detection of Recurrence of Melanoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06246227
• Other study ID #: H-18008586
• Status: Active, not recruiting
• Start date: July 1, 2019
• Est. completion date: January 1, 2028

Study information

• Verified date: March 2024
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study examines circulating tumor DNA (ctDNA) as a biomarker for early detection of recurrence in high-risk patients, following treatment of primary melanoma. The hypothesis is that ctDNA can provide accurate detection of recurrence or metastasis, at the time of or earlier than current methods, leading to improved management and hopefully prognosis, based on earlier detection.

Description:

This prospective, single-institution study will recruit patients attending follow-up for primary melanoma with high risk of recurrence, at the department of Plastic and Reconstructive Surgery, Herlev and Gentofte University Hospital, Copenhagen University.

Enrolled patients will undergo regular blood sampling. Samples will be centrifuged and plasma will be harvested and stored. In cases of metastasis or recurrence, tumor tissue samples will be analyzed using NGS to determine their mutational profile. Plasma samples will be analyzed for ctDNA corresponding to identified mutations. If ctDNA is detected, previous samples will be analyzed in reverse sequential order, until no ctDNA is detected.

Follow-up time after inclusion is five years or end of clinical-follow up, with an interim sample and data analysis scheduled for 2024 and final analysis scheduled for 2027-2028.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 467
• Est. completion date: January 1, 2028
• Est. primary completion date: October 6, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Follow-up for Primary Melanoma, Stages IIB to III and Resected Stage IV

Exclusion Criteria:

• Pregnancy

• Previous history of melanoma

Related Conditions & MeSH terms

• Melanoma
• Recurrence

Locations

Country	Name	City	State
Denmark	Detp. of Pastic and Reconstructive Surgery, Herlev Hospital	Herlev

Sponsors (5)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	CAG in Cancer immunotherapy, Danish Cancer Research Foundation, Danish Cancer Society, DCCC ctDNA Research Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of ctDNA for detection of metastatic disease	By analyzing blood samples of patients diagnosed with recurrence, we will establish the ability of ctDNA to detect known recurrence, and therefore be able to establish the sensitivity of the method.	From enrollment to end of 5-year follow-up
Primary	Specificity of ctDNA for detection of metastatic disease	By assuming no ctDNA in healthy individuals and analyzing WBC from buffy-coat to correct for wild-type mutated DNA due to CHIP, we will be able to establish the specificity of the method.	From enrollment to end of 5-year follow-up
Secondary	Time from detectable ctDNA to clinical og radiological suspicion of recurrence	We will start by analyzing the closest sample to the original suspicion of recurrence. In the event of ctDNA detection, previous samples will be analyzed in reverse sequential order, until no ctDNA is detected. This will allow us to establish a temporal relationship between the ability of ctDNA to detect recurrence and current surveillance methods.	From enrollment to end of 5-year follow-up
Secondary	Associations between ctDNA detection and quantification, and other biomarkers, including LDH, WBC differential, and HS-CRP	By measuring LDH, WBC Diff. and HS-CRP at every sampling, we will be able to establish the correlation between these currently accepted biomarkers for melanoma-specific survival and ctDNA measurements.	From enrollment to end of 5-year follow-up