NCT05572801

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
61mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
4 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Aug 2023Jun 2031

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

August 22, 2022

Last Update Submit

August 13, 2024

Conditions

Anal Cancer

Keywords

Anal cancerCirculating Tumor DNAPlasma HPVFollow-up

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    Disease free survival 2 years from end of therapy

    after 2 years

Secondary Outcomes (11)

  • Time between ctDNA detected and CT verified recurrences

    after 5 years

  • Rate of succesful salvage surgery

    after 5 years

  • Pattern of failure

    after 5 years

  • Disease free survival at 5 years follow-up

    after 5 years

  • The rate of distant failures

    after 5 years

  • +6 more secondary outcomes

Study Arms (3)

ARM A: HPV positive standard of care follow-up

NO INTERVENTION

The national follow-up program + collection of blood samples for retrospective translational research

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

EXPERIMENTAL

The national follow-up program + ctDNA guided additional imaging + collection of blood samples for retrospective translational research

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

ARM O: HPV negative observational arm

NO INTERVENTION

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

Interventions

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

Blood samples in follow-up positive for ctDNA leads to an extra PET-CT scan to detect early treatment failure

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with SCCA eligible for definitive (chemo)radiotherapy
  • ≥ 18 of years
  • Written and oral consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Department of Oncology Herlev and Gentofte Hospital

Herlev, Capital Region of Denmark, 2730, Denmark

RECRUITING

Department of Oncology, Vejle Hospital

Vejle, The Regions of Southern Denmark, 7100, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Tampere University Hospital

Tampere, 33520, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, 20521, Finland

NOT YET RECRUITING

Haukeland University Hospital

Bergen, 5021, Norway

NOT YET RECRUITING

Oslo University Hospital

Oslo, 0450, Norway

NOT YET RECRUITING

University Hospital of North Norway

Tromsø, 9019, Norway

NOT YET RECRUITING

St. Olav's University Hospital

Trondheim, 7030, Norway

NOT YET RECRUITING

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

NOT YET RECRUITING

Skåne University Hospital Lund

Lund, 222 42, Sweden

NOT YET RECRUITING

Karonlinska University Hospital

Stockholm, 171 64, Sweden

NOT YET RECRUITING

Norrlands University Hospital

Umeå, 907 37, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Karen-Lise G Spindler, Professor

    Department of Experimental Clinical Oncology Aarhus Univeristy Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen-Lise G Spindler, Professor

CONTACT

91137244k.g.spindler@rm.dk

Louise V Laursen, Secretary

CONTACT

78454979louise@oncology.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dr. Med.

Study Record Dates

First Submitted

August 22, 2022

First Posted

October 10, 2022

Study Start

August 2, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2031

Last Updated

August 14, 2024

Record last verified: 2024-08

Locations

SE(4)NO(4)FI(2)DK(3)