NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients with SCCA eligible for definitive (chemo)radiotherapy
• ≥ 18 of years
• Written and oral consent
Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Department of Oncology Herlev and Gentofte Hospital
RECRUITING
Herlev
Department of Oncology, Vejle Hospital
RECRUITING
Vejle
Finland
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Turku University Hospital
NOT_YET_RECRUITING
Turku
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Oslo University Hospital
NOT_YET_RECRUITING
Oslo
University Hospital of North Norway
NOT_YET_RECRUITING
Tromsø
St. Olav's University Hospital
NOT_YET_RECRUITING
Trondheim
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Skåne University Hospital Lund
NOT_YET_RECRUITING
Lund
Karonlinska University Hospital
NOT_YET_RECRUITING
Stockholm
Norrlands University Hospital
NOT_YET_RECRUITING
Umeå
Contact Information
Primary
Karen-Lise G Spindler, Professor
k.g.spindler@rm.dk
91137244
Backup
Louise V Laursen, Secretary
louise@oncology.au.dk
78454979
Time Frame
Start Date: 2023-08-02
Estimated Completion Date: 2031-06-01
Participants
Target number of participants: 400
Treatments
No_intervention: ARM A: HPV positive standard of care follow-up
The national follow-up program + collection of blood samples for retrospective translational research
Experimental: ARM B: HPV positive ctDNA guided imaging in follow-up
The national follow-up program + ctDNA guided additional imaging + collection of blood samples for retrospective translational research
No_intervention: ARM O: HPV negative observational arm
Patients with HPV negative disease will be included in an observational arm (ARM O)~ARM O: The national follow-up program + collection of blood samples for retrospective translational research
Related Therapeutic Areas
Sponsors
Collaborators: Nordic Cancer Union, Danish Comprehensive Cancer Center, The regions medicine- and treatment funds
Leads: Aarhus University Hospital