RecruitingOBSERVATIONAL

Outcomes of Low-Risk Endometrial Cancer With Isolated Tumor Cells in the Sentinel Lymph Nodes: A Prospective, Multicenter, Single-Arm Observational Study

This study is for women diagnosed with a specific type and stage of womb cancer, known as low-risk endometrial endometrioid adenocarcinoma (FIGO Grade 1 or 2, Stage IA1 or IA2). The main aim is to understand if finding very tiny, isolated cancer cells in the 'sentinel' lymph nodes (the first lymph nodes where cancer cells might spread) affects a patient's long-term health. Researchers will compare how often the cancer comes back in patients with these tiny cells to those who didn't have any cancer cells in their lymph nodes. This is an observational study, meaning participants won't receive new treatments, but their existing medical records and tissue samples will be reviewed to gather information.

At a glance

Status

Recruiting

Sponsor

Mayo Clinic

Enrolment target

212

Start

04 Dec 2024

Estimated completion

31 Oct 2029

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma Stage IA1 Endometrial Cancer FIGO 2023 Stage IA2 Endometrial Cancer FIGO 2023

What is this study about?

This research is looking into a common type of womb cancer (endometrial cancer) that is caught early and is considered low-risk. When someone has surgery for this cancer, doctors often check nearby lymph nodes to see if the cancer has spread. Sometimes, they find very small, individual cancer cells in these 'sentinel' lymph nodes that are hard to spot.

Researchers want to understand if finding these tiny, isolated cancer cells (called 'isolated tumour cells' or ITC) means anything different for a patient's future health compared to those whose lymph nodes are completely clear. They are particularly interested in whether having these cells makes it more likely for the cancer to come back later on. By reviewing medical records of patients who have already had standard surgery, they hope to get a clearer picture.

This study is important because understanding the meaning of these tiny cells could help doctors decide if some patients need closer follow-up or different advice, even with low-risk cancer. It's about learning more to give better care in the future. It's important to remember this is an observational study, so no new treatments are being tested; it's about looking at existing information.

Key takeaways

Study for women with early-stage, low-risk womb cancer.
Investigates if tiny cancer cells in lymph nodes affect future health.
It's an 'observational' study, reviewing existing medical records only.
No new treatments, medicines, or appointments needed.
Aims to improve understanding and future care for patients.
Participation involves giving consent to use your anonymous medical data.

Who may be eligible?

You might be able to take part in this study if you are a woman who has been diagnosed with a specific type of early-stage womb cancer. This means your cancer must be an 'endometrioid' type, either Grade 1 or 2, and classified as Stage IA1 or IA2 according to the usual medical staging system.

You also need to have had full surgery, including a procedure to check your lymph nodes (called a sentinel lymph node biopsy). A key part of being eligible is that after your surgery, doctors found only very tiny, isolated cancer cells (not bigger groups) in these sentinel lymph nodes. You should not have received any additional cancer treatment (like chemotherapy or radiotherapy) after your surgery, and you shouldn't have plans to receive any. Also, you shouldn't have other serious cancers or significant spread of these cancer cells in your lymph nodes.

If you have already received chemotherapy before surgery, or if you have a different type of cancer or larger amounts of cancer spread in your lymph nodes (called micrometastasis or macrometastasis), you would not be able to join this study. The medical team would review your specific situation to see if you meet all the criteria.

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 diagnosed with FIGO Grade 1 or 2 endometrioid womb cancer?
Is my womb cancer classified as Stage IA1 or IA2?
Did my surgery include checking the lymph nodes (sentinel lymph node biopsy)?
Were only very tiny cancer cells found in my lymph nodes, not larger groups?
Have I not had any chemotherapy before my surgery?
Am I not planning to have additional cancer treatment after my surgery?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't need to do anything extra or have any new procedures. This is an 'observational' study, meaning the researchers will simply gather information from your existing medical records, including details about your diagnosis, surgery, treatment, and follow-up. They will also look at tissue samples collected during your surgery. There are no study visits, extra tests, or new medications or treatments involved. Your participation would involve giving permission for your medical information to be used for this research.

Potential risks and benefits

There are no direct medical risks to you by participating in this study since no new treatments or procedures are involved. Your personal information will be kept confidential. While there's no direct benefit to you personally, your participation will help doctors better understand low-risk womb cancer and the importance of tiny cancer cells in lymph nodes. This understanding could lead to improved care for others in the future. Remember, you have the right to withdraw your consent at any time without affecting your medical care.

Locations (20)

Mayo Clinic in Rochester
Verified postcode
Rochester, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Houston Methodist Hospital
Verified postcode
Houston, United States· Recruiting
Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
AC Camargo Cancer Center
Verified postcode
São Paulo, Brazil· Recruiting
Sunnybrook Health Sciences, University of Toronto
Verified postcode
Toronto, Canada· Recruiting
Hopital Maisonneuve Rosemont
Verified postcode
Montreal, Canada· Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Verified postcode
Toulouse, France· Not yet recruiting
University Hospital Essen
Verified postcode
Essen, Germany· Not yet recruiting
Meir Medical Center, Faculty of Medicine - Tel-Aviv University
Verified postcode
Kefar Sava, Israel· Not yet recruiting
Ospedale Michele e Pietro Ferrero
Verified postcode
Verduno, Italy· Not yet recruiting
IRCCS Fondazione San Gerardo dei Tintori
Verified postcode
Monza, Italy· Not yet recruiting

Common questions

What is an 'observational study'?

It means researchers are just watching and gathering information from existing medical records and samples. You won't receive new treatments or do anything different.

What are 'isolated tumour cells'?

These are very tiny, individual cancer cells sometimes found in the lymph nodes, too small to be a 'spread' of cancer.

Will I have to take any new medicines?

No, this study does not involve any new medicines, treatments, or extra tests. It only uses information already collected from your medical care.

Will this study change my current treatment plan?

No, your current medical care and treatment plan will not be affected or changed by being part of this study.

Is my personal information protected?

Yes, all your medical information will be kept strictly private and anonymous in the study.

How to find out more

Clinical Trials Referral Office

mayocliniccancerstudies@mayo.edu 855-776-0015 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.