Using blood tests to improve follow-up care for anal cancer
NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
This study is testing if blood tests that check for tumor DNA can help doctors find out sooner if anal cancer treatment isn't working or if the cancer comes back, so patients can get better care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 13 sites (Herlev, Capital Region of Denmark and 12 other locations) |
| Trial ID | NCT05572801 on ClinicalTrials.gov |
What this trial studies
This study investigates whether circulating tumor DNA (ctDNA) can enhance the detection of early treatment failures or recurrences in patients with localized squamous cell carcinoma of the anus (SCCA) after receiving curative chemoradiotherapy. By comparing standard follow-up programs with ctDNA-guided imaging follow-up, the study aims to improve patient outcomes and increase the chances of curative surgery. Additionally, it seeks to establish early interventions to manage late morbidities associated with the disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with localized squamous cell carcinoma of the anus who are eligible for definitive chemoradiotherapy.
Not a fit: Patients with conditions that contraindicate blood sampling or PET-CT scans, or those who may not comply with the follow-up program, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of treatment failures, improving survival rates for patients with anal cancer.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer treatment responses, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with SCCA eligible for definitive (chemo)radiotherapy * ≥ 18 of years * Written and oral consent Exclusion Criteria: * 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.
Where this trial is running
Herlev, Capital Region of Denmark and 12 other locations
- Department of Oncology Herlev and Gentofte Hospital — Herlev, Capital Region of Denmark, Denmark (Recruiting)
- Department of Oncology, Vejle Hospital — Vejle, The Regions of Southern Denmark, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Tampere University Hospital — Tampere, Finland (Not_yet_recruiting)
- Turku University Hospital — Turku, Finland (Not_yet_recruiting)
- Haukeland University Hospital — Bergen, Norway (Not_yet_recruiting)
- Oslo University Hospital — Oslo, Norway (Not_yet_recruiting)
- University Hospital of North Norway — Tromsø, Norway (Not_yet_recruiting)
- St. Olav's University Hospital — Trondheim, Norway (Not_yet_recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Skåne University Hospital Lund — Lund, Sweden (Not_yet_recruiting)
- Karonlinska University Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Norrlands University Hospital — Umeå, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Karen-Lise G Spindler, Professor — Department of Experimental Clinical Oncology Aarhus Univeristy Hospital
- Study coordinator: Karen-Lise G Spindler, Professor
- Email: k.g.spindler@rm.dk
- Phone: 91137244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.