TROPICCANA: A new blood test to monitor treatment in patients with cervical cancer

ISRCTN	ISRCTN17304563
DOI	https://doi.org/10.1186/ISRCTN17304563
Integrated Research Application System (IRAS)	310379
Sponsor	Royal Marsden NHS Foundation Trust
Funders	Lady Garden Foundation, RadNet at The Institute of Cancer Research and The Royal Marsden

Submission date: 05/02/2026
Registration date: 17/04/2026
Last edited: 17/04/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Every year in the UK approximately 3000 patients are diagnosed with cervix cancer caused by Human Papilloma Virus (HPV) infection. The standard treatment for cervix cancer that cannot be removed with surgery is either radiotherapy alone or chemoradiotherapy and brachytherapy. At 12 weeks after treatment has completed all patients will have an MRI and a PET/CT scan. Mostly, these scans will show a good result, but sometimes it can be difficult to say that the cancer has completely gone. This can cause concern to patients and lead to other tests and biopsies and sometimes surgery. However, most often, if the scans are repeated 3 months later, the cancer will have resolved. Cervix cancer can sometimes relapse after successful treatment and early detection of relapse is vital to the success of subsequent treatment. Currently we rely on clinical inspection of the cervix and annual scans to follow up and detect relapse. Therefore, a more reliable test to both response at 3 months and to monitor for relapse cancer after treatment is needed.
All invasive cervix cancers release fragments into the blood which contain DNA. In HPV positive cancers these fragments from the cancer will contain HPV DNA. The presence of HPV DNA in the bloodstream can help researchers identify if a patient has any remaining cancer after the completion of their treatment. HPV-detect is a new test developed by researchers at The Royal Marsden Hospital (RMH) and The Institute of Cancer Research, London. HPV-detect has already been tested in a small study carried out at RMH in cervix cancer patients. The study showed that the HPV-detect test could detect HPV DNA (released from HPV positive tumours) in the bloodstream of more than 90% patients. The study also showed that patients with no HPV DNA in their blood after treatment did not relapse. This supports the accuracy of the HPV-detect test. However, further testing of HPV-detect in a larger study is needed. The aim of the TROPICCANA study is to find out if HPV-detect can accurately confirm that no disease remains after chemoradiotherapy and thus reassure patients with equivocal scans. The study will also assess whether HPV-detect can be used to detect relapse sooner than examination or imaging.

Who can participate?
Adults over the age of 18 years who are receiving chemoradiation for locally advanced cervix cancer.

What does the study involve?
TROPICCANA is a blood and tissue sample collection and data analysis study. It does not involve any additional screening tests, treatments or visits to the hospital. Participants will be asked to donate one blood sample before treatment and up to eight blood samples during treatment and follow-up. Participants will also be asked to donate the tumour sample that was collected from the cervix when they were diagnosed and any additional tissue samples that are routinely collected after their treatment.

What are the possible benefits and risks of participating?
This is a voluntary research study and will not be of direct benefit to those taking part but may prove to be of benefit to others in the future.
Participants will be required to give frequent blood samples that would not be required otherwise. Risks linked with collecting blood samples from an arm include pain from the needle being inserted, bruising, light-headedness, possible fainting, and (rarely) infection.

Where is the study run from?
The TROPICCANA study is being run by The Royal Marsden NHS Foundation Trust in the United Kingdom.

When is the study starting and how long is it expected to run for?
From January 2026 to July 2030

Who is funding the study?
Lady Garden Foundation and CRUK RM/ICR RadNet Centre

Who is the main contact?
Dr Susan Lalondrelle
Susan.Lalondrelle@rmh.nhs.uk

Lay summary under review with external organisation

Contact information

Dr Susan Lalondrelle
Principal investigator, Scientific

The Royal Marsden NHS Foundation Trust
Oak Cancer Centre
16 Oakleaf Avenue
Sutton
SM2 5GP
United Kingdom

Phone	+44 20 8915 4143
Email	Susan.Lalondrelle@rmh.nhs.uk

Agnieszka Niebrzydowska
Public

The Royal Marsden NHS Foundation Trust
Oak Cancer Centre
16 Oakleaf Avenue
Sutton
SM2 5GP
United Kingdom

Phone	+44 20 8915 6666
Email	Agnieszka.Niebrzydowska@rmh.nhs.uk

Study information

Primary study design	Observational
Observational study design	Cohort study
Scientific title	Treatment Response In Cervix Cancer Assessed by circulating HPV DNA
Study acronym	TROPICCANA
Study objectives	Primary objective: Validation of cHPV-DNA, measured using ddPCR as a predictor of residual disease following primary chemoradiotherapy for locally advanced cervix cancer. Secondary objectives: 1. To compare cHPV-DNA with MRI and PET-CT as a marker of residual disease 2. To assess if cHPV-DNA can be used to detect relapse during follow-up 3. To compare cHPV-DNA with MRI and PET-CT as a marker of disease relapse following successful treatment 4. To measure cHPV-DNA levels at baseline and during follow-up.
Ethics approval(s)	Approved 26/01/2026, South Central - Oxford A REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; oxforda.rec@hra.nhs.uk), ref: 26/SC/0016
Health condition(s) or problem(s) studied	Patients with locally advanced cervix cancer receiving chemoradiation.
Intervention	TROPICCANA is a blood and tissue sample collection and data analysis study. It does not involve any additional screening tests, treatments or visits to the hospital. Participants will be asked to donate one blood sample before treatment and up to eight blood samples during treatment and follow-up. Participants will also be asked to donate the tumour sample that was collected from the cervix when they were diagnosed and any additional tissue samples that are routinely collected after their treatment. Participants will receive standard of care treatment and follow-up. Participants will continue their clinical examinations and imaging as per standard of care. Disease status will be collected during follow-up up to 3 years. Participants' treatment plans will not be altered based on the HPV-detect test results.
Intervention type	Other
Primary outcome measure(s)	Specificity of cHPV-DNA measured using proportion of all patients confirmed negative for residual disease (diagnosed via imaging and clinical follow-up to 24 months) who have undetectable ctDNA levels at 3 months post-treatment, residual disease status confirmed by follow-up to 24 months post-treatment
Key secondary outcome measure(s)	Association between cHPV-DNA detection at each timepoint and disease status (recurrence/not recurrence) based on clinical examination at the same timepoint measured using proportion of patients with disease recurrence (diagnosed via clinical exam) at each timepoint, in patients grouped by ctDNA status (detected vs undetected) at 6 months, 9 months, 12 months, 18 months, and 24 months post-treatment. Association between cHPV-DNA detection at each timepoint between 6 to 18 months, and the presence of any recorded disease recurrence from that timepoint up to 24 months post-treatment measured using proportion of patients with disease recurrence (diagnosed via imaging or clinical exam up to 24 months post-treatment) at each timepoint, in patients grouped by ctDNA status (detected vs undetected) at 6 months, 9 months, 12 months, 18 months post-treatment, residual disease status confirmed by follow-up to 24 months post-treatment. Association between cHPV-DNA detection at 24 months, and the presence of any recorded disease recurrence from that timepoint up to 3 years post-treatment measured using proportion of patients with disease recurrence (diagnosed via imaging or clinical exam up to 36 months post-treatment), in patients grouped by ctDNA status at 24 months post-treatment (detected vs undetected) at 24 months post-treatment, residual disease status confirmed by follow-up to 36 months post-treatment Sensitivity and specificity of cHPV-DNA levels compared to tissue HPV tissue status at baseline and during follow-up measured using proportion of patients with disease recurrence (diagnosed via imaging or clinical exam up to 24 months post-treatment) at each timepoint, in patients grouped by tissue HPV status (positive vs negative) at 3 months, 6 months, 9 months, 12 months, and 18 months post-treatment
Completion date	30/07/2030

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	131
Key inclusion criteria	1. Age 18 years or older 2. Patients with histologically confirmed Stage 1B-4A (FIGO 2018) histologically confirmed HPV associated carcinoma of the cervix 3. Planned to receive radical radiotherapy or chemoradiotherapy 4. Treatment and follow-up within the same hospital or centre 5. Ability to give informed consent for biological sample collection
Key exclusion criteria	1. Previous or concurrent illness or situation, which in the investigator’s opinion would interfere with completion of the sample collection 2. Any invasive malignancy within the previous 2 years (other than non-melanomatous skin carcinoma or cervical carcinoma in situ)
Date of first enrolment	30/01/2026
Date of final enrolment	30/07/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Royal Marsden NHS Foundation Trust

Fulham Road
London
SW3 6JJ
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

05/02/2026: Trial's existence confirmed by South Central - Oxford A REC.