Active not recruitingNAINTERVENTIONAL

Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses (CIRCA-HPV)

This study, called CIRCA-HPV, is looking for a better way to check if certain pelvic cancers (like cervical, anal, vaginal, vulval, or penile cancers) that are caused by HPV might return. We're interested in people who have already had treatment for these cancers and who are now in the follow-up stage. The main idea is to see if a special blood test, which looks for tiny fragments of cancer DNA (called ctDNA), can spot any signs of the cancer coming back earlier than traditional methods. By doing this, we hope to find relapses sooner, which could lead to better outcomes. Participants will have regular blood tests during their routine hospital visits over 2.5 years.

At a glance

Status

Active not recruiting

Phase

Sponsor

Institut Curie

Enrolment target

172

Start

24 Jan 2019

Estimated completion

01 Jun 2026

HPV Positive Pelvic Cancer

What is this study about?

This study is called CIRCA-HPV and it aims to improve how we detect if certain pelvic cancers come back after treatment. These are cancers that are linked to the Human Papillomavirus (HPV), such as some cervical, anal, vaginal, vulval, or penile cancers. If you've been treated for one of these cancers and are now regularly checked by your doctors, this study might be relevant to you. The main goal is to find out if a new type of blood test can spot signs of cancer returning earlier than current methods.

At the moment, after treatment for cancer, doctors regularly monitor patients to make sure the cancer hasn't come back. This often involves physical exams and sometimes scans. This study wants to see if a simple blood test, which looks for something called 'circulating tumour DNA' (ctDNA), can give us an early warning. ctDNA is like a tiny fingerprint left behind by cancer cells in your bloodstream. If we can find these fingerprints early, it means doctors might be able to act faster if the cancer does return.

This research is important because finding out early if cancer has come back can make a big difference in how it's managed. If this blood test proves to be effective, it could become a valuable tool for doctors in the future, providing a less invasive and potentially earlier way to monitor patients after their initial cancer treatment.

Key takeaways

This study uses a simple blood test to look for early signs of HPV-related pelvic cancer returning.
It's for people who have already been treated for certain HPV-related pelvic cancers and are now in follow-up.
Participation involves giving blood samples at your regular hospital visits for 2.5 years.
The goal is to find if this new test can spot cancer recurrence sooner, potentially improving outcomes.
Your routine medical care will not be affected by taking part in this study.

Who may be eligible?

This study is looking for adults aged 18 or over who have previously been treated for certain HPV-related pelvic cancers. This includes specific stages of cervical, anal, vaginal, vulval, or penile cancer, and your treatment must have finished within the last three years. Crucially, you must currently be free of any signs of cancer.

You also need to have proof that your original cancer was caused by HPV, perhaps from a previous test. It's important that you have regular follow-up appointments scheduled at the hospital where you're being seen for the study, at least twice a year. You should be able to understand the study information and be willing to sign a consent form to take part. This study is currently open to those affiliated with the French social security system.

However, you cannot take part if you currently have active cancer, if you're unable to make your own decisions about your health, or if personal circumstances (like where you live or other issues) would make it difficult for you to attend regular follow-up appointments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been treated for a specific HPV-related pelvic cancer in the last 3 years?
Am I currently free of any signs of cancer?
Am I aged 18 or older?
Do I have proof that my original cancer was HPV-related?
Do I have regular follow-up appointments scheduled at the hospital?
Am I able to understand the study and agree to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be followed for about two and a half years. During this time, at each of your routine hospital visits, you'll be asked to give a blood sample. These blood samples will be used to look for the tiny cancer DNA fragments we mentioned earlier. At these visits, your doctors will also gather information about your health, such as new symptoms, standard blood tests you might have (like an SCC marker test), and any scan results if you happen to have them.

If, during the 2.5 years, your cancer unfortunately comes back, your participation in the study for blood sampling will stop on that date. If, however, you go through the full 2.5 years without the cancer returning, we'll continue to keep an eye on you for another six months (plus two weeks). During this extra time, you won't have any special study procedures; we'll just check if there are any signs of cancer returning later on.

Potential risks and benefits

The main benefit of taking part in this study is that it might help us understand if a new blood test can detect cancer returning earlier. This knowledge could help improve care for future patients. For you personally, while the study itself doesn't offer direct medical treatment, any concerning results from the blood tests would be shared with your doctors, who would then decide on the best course of action. The main risks are minor, mostly from having blood samples taken, which can sometimes cause a small bruise or discomfort. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

CHU de Besançon
Verified postcode
Besançon, France
Institut Curie - Paris
Verified postcode
Paris, France
Hôpital Tenon
Verified postcode
Paris, France
CHU Pontchaillou
Verified postcode
Rennes, France
Institut Curie - Saint-Cloud
Verified postcode
Saint-Cloud, France

Common questions

What is HPV and why is it important for this study?

HPV stands for Human Papillomavirus. It's a common virus that can cause certain types of cancer, including some pelvic cancers. This study specifically looks at cancers caused by HPV.

What is a 'pelvic cancer'?

Pelvic cancers are cancers that start in the lower part of your tummy, known as the pelvis. This can include cancers of the cervix, anus, vagina, vulva, or penis.

What is ctDNA?

ctDNA stands for 'circulating tumour DNA'. It's tiny pieces of DNA that cancer cells can release into your bloodstream. This study wants to see if we can find these tiny pieces to detect if cancer has returned early.

Will I get any extra treatment if I join this study?

No, this study is about monitoring and detection, not new treatments. If any worrying results are found, your doctors will decide on your treatment based on existing medical guidelines.

How many times will I have to give blood?

You'll provide a blood sample at each of your routine scheduled hospital follow-up visits during the 2.5 years you're part of the study.