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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-02

Study Completion Date

2031-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ARM A: HPV positive standard of care follow-up

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

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

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

ARM O: HPV negative observational arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Karen-Lise Garm Spindler

Professor, Dr. Med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen-Lise G Spindler, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Experimental Clinical Oncology Aarhus Univeristy Hospital

Locations

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Department of Oncology Herlev and Gentofte Hospital

Herlev, Capital Region of Denmark, Denmark

Site Status RECRUITING

Department of Oncology, Vejle Hospital

Vejle, The Regions of Southern Denmark, Denmark

Site Status RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING