Investigating blood biomarkers in anal cancer patients undergoing chemotherapy
Circulating Biomarkers in Patients With Anal Cancer Treated With Induction Chemotherapy
This study is testing if certain blood markers can help predict how well anal cancer patients respond to chemotherapy and their chances of survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 3 sites (Aarhus, Aarhus N and 2 other locations) |
| Trial ID | NCT05233540 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the prognostic and predictive value of plasma HPV levels in patients with locally advanced squamous cell carcinoma of the anus who are receiving induction chemotherapy before definitive treatment. It will analyze changes in circulating tumor DNA and other relevant markers during and after treatment to predict patient response and survival outcomes. The research is conducted at three major oncology departments in Denmark, focusing on a rare cancer type that is often linked to HPV. By understanding these biomarkers, the study seeks to improve treatment strategies for anal cancer patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed squamous cell carcinoma of the anus who are receiving induction chemotherapy.
Not a fit: Patients with contraindications for blood sampling or other malignancies within the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for anal cancer, improving patient outcomes.
How similar studies have performed: While the specific approach of this study is novel, previous research has shown promise in using circulating biomarkers for cancer prognosis and treatment response.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological verified squamous cell carcinoma of the anus * Treatment with ICT prior to definitive CRT or RT due to locally advanced disease or * Patients with synchronous metastatic disease treated with ICT with the purpose of definitive CRT (potentially in combination with organ directed therapy (surgery, RFA, SBRT) for the metastatic sites) * Age ≥ 18 years * Written and orally informed consent Exclusion Criteria: * Contraindications for blood sampling * Other malignancy within the past five years, with exception of basal cell carcinoma
Where this trial is running
Aarhus, Aarhus N and 2 other locations
- Department of Oncology, Aarhus University Hospital — Aarhus, Aarhus N, Denmark (Recruiting)
- Department of Oncology Herlev and Gentofte Hospital — Herlev, Denmark (Not_yet_recruiting)
- Department of Oncology, Vejle hospital, University Hospital of Southern Denmark — Vejle, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Karen L Wind, MD — Aarhus University Hospital
- Study coordinator: Karen L Wind, MD
- Email: karen.lycke.wind@auh.rm.dk
- Phone: 20614431
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.