NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer

Last updated: August 13, 2024
Sponsor: Aarhus University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anal Dysplasia

Rectal Cancer

Rectal Disorders

Treatment

AMR B: HPV positive ctDNA guided imaging in follow-up

Clinical Study ID

NCT05572801
82386
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients with SCCA eligible for definitive (chemo)radiotherapy

  • ≥ 18 of years

  • Written and oral consent

Exclusion

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.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: AMR B: HPV positive ctDNA guided imaging in follow-up
Phase:
Study Start date:
August 02, 2023
Estimated Completion Date:
June 01, 2031

Study Description

Squamous cell carcinoma of the anus (SCCA) is a rare disease with less than 200 new cases in Denmark and Sweden each year and approximately 100 new cases in Norway and Finland but with increasing incidence. Primary treatment is chemo-radiotherapy (CRT) comprising high dose IMRT based radiation therapy with combination chemotherapy of 5-FU and Cisplatin. Overall treatment response is good in small tumors, but less pronounced for high-risk tumors.

In absence of complete pathological response after CRT or local recurrence, patients are evaluated for. salvage surgery. The importance of R0 resection on overall survival has been described in several studies. It is suggested that early detection of treatment failure and recurrences increases the chance of possible curative surgery (R0-resection) and thereby overall survival.

A follow-up program has 3 purposes

  1. To detect lack of complete response to primary treatment

  2. Early detection of local or distant recurrences

  3. Describing and managing late morbidity

Purpose:

The main purpose of this follow-up study is to investigate if circulating tumor tDNA can improve detection of early treatment failure or recurrences thereby assisting in increasing the potential for cure. Secondly, to provide evidence for use of imaging and third objective is to establish early intervention against late morbidities.

Connect with a study center

  • Department of Oncology Herlev and Gentofte Hospital

    Herlev, Capital Region Of Denmark 2730
    Denmark

    Active - Recruiting

  • Department of Oncology, Vejle Hospital

    Vejle, The Regions Of Southern Denmark 7100
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8000
    Denmark

    Active - Recruiting

  • Tampere University Hospital

    Tampere, 33520
    Finland

    Site Not Available

  • Turku University Hospital

    Turku, 20521
    Finland

    Site Not Available

  • Haukeland University Hospital

    Bergen, 5021
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo, 0450
    Norway

    Site Not Available

  • University Hospital of North Norway

    Tromsø, 9019
    Norway

    Site Not Available

  • St. Olav's University Hospital

    Trondheim, 7030
    Norway

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg, 413 45
    Sweden

    Site Not Available

  • Skåne University Hospital Lund

    Lund, 222 42
    Sweden

    Site Not Available

  • Karonlinska University Hospital

    Stockholm, 171 64
    Sweden

    Site Not Available

  • Norrlands University Hospital

    Umeå, 907 37
    Sweden

    Site Not Available

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