RecruitingNot ApplicableNCT05572801

NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer

NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up


Sponsor

Aarhus University Hospital

Enrollment

400 participants

Start Date

Aug 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a blood test that detects cancer DNA (called circulating tumor DNA or ctDNA) can help guide follow-up care for people with anal cancer after treatment. The goal is to see if this simple blood test can detect cancer returning earlier than standard imaging. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the anus (anal cancer) - You are eligible for definitive treatment with radiation therapy (with or without chemotherapy) - You are 18 or older - You can provide written and verbal consent **You may NOT be eligible if...** - You have a condition preventing blood draws - You have a condition preventing a PET-CT scan - You are unlikely to be able to comply with the follow-up program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAMR B: HPV positive ctDNA guided imaging in follow-up

Blood samples in follow-up positive for ctDNA leads to an extra PET-CT scan to detect early treatment failure


Locations(13)

Department of Oncology Herlev and Gentofte Hospital

Herlev, Capital Region of Denmark, Denmark

Department of Oncology, Vejle Hospital

Vejle, The Regions of Southern Denmark, Denmark

Aarhus University Hospital

Aarhus, Denmark

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital

Oslo, Norway

University Hospital of North Norway

Tromsø, Norway

St. Olav's University Hospital

Trondheim, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital Lund

Lund, Sweden

Karonlinska University Hospital

Stockholm, Sweden

Norrlands University Hospital

Umeå, Sweden

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NCT05572801


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