Using blood tests to improve follow-up care for anal cancer
Official title: NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
Run by Aarhus University Hospital · NCT05572801 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 13 sites (Herlev, Capital Region of Denmark and 12 other locations) |
| Status | Recruiting |
| Started | August 2, 2023 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2031 |
| Registry record updated | August 14, 2024 |
| Trial ID | NCT05572801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using ctDNA for monitoring cancer treatment responses, suggesting that this approach may be effective.
Who can join: the full rules
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 it's running
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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
Show 7 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Retifanlimab after chemoradiation for anal cancer
This study tests whether retifanlimab can help people with anal squamous cell carcinoma who have completed chemoradiation and still have residual disease.
-
Irreversible Electroporation for Recurrent Pelvic Tumors
This study tests whether using irreversible electroporation (IRE) is safe and helps control recurrent pelvic tumors in adults who can’t have other local treatments.
-
HPV DNA-guided chemoradiation with Retifanlimab for locally advanced anal cancer
This study tests whether adjusting chemoradiation doses based on HPV ctDNA results and adding Retifanlimab after CRT can improve outcomes for adults with new, locally advanced anal cancer.
-
Gynecological and sexual health after radiotherapy for anal cancer.
See if vaginal problems and changes in sexual health are linked to radiation dose in women treated with chemoradiotherapy for anal cancer 6–36 months after treatment.
-
Self-sampling to improve anal lesion outcomes
This study will test whether people at higher risk for anal cancer will use a self-collected anal swab and whether that increases follow-up cytology and high-resolution anoscopy (HRA) appointment attendance.
-
Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors
This will test whether trastuzumab deruxtecan (T‑DxD) helps adults in the US with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have had prior systemic treatment and have no satisfactory alternative options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.