Anal CancerNCT05572801
NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer
A study testing AMR B: HPV positive ctDNA guided imaging in follow-up in people with Anal Cancer, run by Aarhus University Hospital at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- What is being tested?
- AMR B: HPV positive ctDNA guided imaging in follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 2 Aug 2023to 1 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with SCCA eligible for definitive (chemo)radiotherapy
- ≥ 18 of years
- Written and oral consent
Who cannot join
- 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.
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
Norway4 sites, 4 recruiting
- Not yet recruiting
Haukeland University Hospital
Bergen, 5021
Janne B Kjersem
- Not yet recruiting
Oslo University Hospital
Oslo, 0450
Marianne G Guren
- Not yet recruiting
University Hospital of North Norway
Tromsø, 9019
Magnar Johansen
- Not yet recruiting
St. Olav's University Hospital
Trondheim, 7030
Eva Hofsli
Sweden4 sites, 4 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg, 413 45
Mia Johansson
- Not yet recruiting
Skåne University Hospital Lund
Lund, 222 42
Anders Johnsson
- Not yet recruiting
Karonlinska University Hospital
Stockholm, 171 64
Carl Henrik Shah
Calin Radu
- Not yet recruiting
Norrlands University Hospital
Umeå, 907 37
Birgitta Lindh
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Karen-Lise G Spindler
- Recruiting
Department of Oncology Herlev and Gentofte Hospital
Herlev, Capital Region of Denmark, 2730
Eva Serup-Hansen
- Recruiting
Department of Oncology, Vejle Hospital
Vejle, The Regions of Southern Denmark, 7100
Birgitte M. Havelund
Finland2 sites, 2 recruiting
- Not yet recruiting
Tampere University Hospital
Tampere, 33520
Pia Österlund
- Not yet recruiting
Turku University Hospital
Turku, 20521
Annika Ålgars
About this study
Official title: NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
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.
Read the detailed 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
- To detect lack of complete response to primary treatment
- Early detection of local or distant recurrences
- 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
- Anal Cancer
- Being tested
- AMR B: HPV positive ctDNA guided imaging in follow-up
- Keywords
- Anal cancer, Circulating Tumor DNA, Plasma HPV, Follow-up
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Disease free survival 2 years from end of therapy
Measured: after 2 years
Secondary outcomes (11)
Time between ctDNA detected and CT verified recurrences
Lead time between ctDNA detected and CT verified recurrences
Measured: after 5 years
Rate of succesful salvage surgery
Rate of succesful salvage surgery
Measured: after 5 years
Pattern of failure
Pattern of failure defined as ln-field failures (within GTV-T, GTV-N, CTV or irradiated areas) or out-of-field failures
Measured: after 5 years
Disease free survival at 5 years follow-up
Disease free survival at 5 years follow-up
Measured: after 5 years
The rate of distant failures
The rate of distant failures
Measured: after 5 years
Overall survival
Overall survival from beginning of treatment to death of any cause
Measured: 5 years
Explorative analysis of total circulating free DNA (cfDNA)
Explorative analysis of total circulating free DNA (cfDNA)
Measured: 5 years
ctDNA assays for HPV negative cases
Analysis of ctDNA in HPV negative cases
Measured: 5 years
Acute toxicity
Acute toxicity (CTCAE 5.0)
Measured: after 2 and 5 years
Late toxicity
Late toxicity (CTCAE 5.0)
Measured: after 2 and 5 years
Health related quality of life
Health related quality of life (EORTC QLQ-ANL27)
Measured: after 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start2 Aug 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Comprehensive Cancer Center, Nordic Cancer Union, The regions medicine- and treatment funds
- Responsible party
- Principal investigator, Karen-Lise Garm Spindler, Aarhus University Hospital
- Investigators
- Karen-Lise G Spindler, Professor, Principal investigator, Department of Experimental Clinical Oncology Aarhus Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572801
- Sponsor's protocol ID
- 82386
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2022
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
- ClinicalTrials.gov ID
- NCT05572801
- Acronym / sponsor ID
- 82386
- Conditions
- Anal Cancer
- Keywords
- Anal cancer, Circulating Tumor DNA, Plasma HPV, Follow-up
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Danish Comprehensive Cancer Center, Nordic Cancer Union, The regions medicine- and treatment funds
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- To detect lack of complete response to primary treatment
- Early detection of local or distant recurrences
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: AMR B: HPV positive ctDNA guided imaging in follow-upThe national follow-up program + ctDNA guided additional imaging + collection of blood samples for retrospective translational research |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with SCCA eligible for definitive (chemo)radiotherapy
- ≥ 18 of years
- Written and oral consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMR B: HPV positive ctDNA guided imaging in follow-upBlood samples in follow-up positive for ctDNA leads to an extra PET-CT scan to detect early treatment failure | Diagnostic test | ARM B: HPV positive ctDNA guided imaging in follow-up |
Primary outcome
Disease free survival
Time frame: after 2 years
Disease free survival 2 years from end of therapy
11 secondary outcomes
Time between ctDNA detected and CT verified recurrences
Time frame: after 5 years
Rate of succesful salvage surgery
Time frame: after 5 years
Pattern of failure
Time frame: after 5 years
Disease free survival at 5 years follow-up
Time frame: after 5 years
The rate of distant failures
Time frame: after 5 years
Overall survival
Time frame: 5 years
Explorative analysis of total circulating free DNA (cfDNA)
Time frame: 5 years
ctDNA assays for HPV negative cases
Time frame: 5 years
Acute toxicity
Time frame: after 2 and 5 years
Late toxicity
Time frame: after 2 and 5 years
Health related quality of life
Time frame: after 2 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen-Lise G Spindler, Professor principal investigator
Department of Experimental Clinical Oncology Aarhus Univeristy Hospital
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMR B: HPV positive ctDNA guided imaging in follow-up in people with Anal Cancer, run by Aarhus University Hospital at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Norway, Sweden, Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen-Lise G Spindler, Professor (91137244, k.g.spindler@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: after 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.