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

Inclusion Criteria3

  • Patients with SCCA eligible for definitive (chemo)radiotherapy
  • ≥ 18 of years
  • Written and oral consent

Exclusion Criteria3

  • Conditions that will contraindicate blood samples
  • Conditions that will contraindicate a PET-CT scan.
  • Potential lack of compliance to standard FU program and study participation.

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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