All studies
RecruitingInterventional

The DISC Pilot study: testing if taking extra tissue during breast surgery helps make treatment more successful

This study, called DISC, is investigating a new way to remove a type of early breast cancer called Ductal Carcinoma in Situ (DCIS). Currently, some women need a second operation if not all cancerous cells are removed in the first surgery, which can be worrying and delay recovery. This research aims to see if taking a small amount of extra healthy tissue around the cancer during the first operation could help prevent a second surgery. The study will compare the usual surgery with this new method. Researchers will look at how many women need a second operation, their experience, and how their breast looks afterwards. This pilot study will help design a larger study in the future. It's for women aged 18-90 with a new diagnosis of DCIS who haven't had previous radiotherapy to that breast.

At a glance

Status
Recruiting
Sponsor
City St George's, University of London
Enrolment target
26
Start
09 Jan 2026
Estimated completion
26 Sep 2026

What is this study about?

When you have breast cancer surgery, especially a lumpectomy (where only the lump is removed), the goal is to take out all the cancer. Sometimes, after the first operation, doctors find that some cancer cells might be very close to the edges of where the tissue was removed. If this happens, you might need a second operation to make sure all the cancer is gone. This can be stressful, delay other treatments like radiotherapy, and affect how your breast looks.

This study is focusing on a specific type of very early breast cancer called Ductal Carcinoma in Situ, or DCIS. With DCIS, it's more common to need a second operation compared to other types of breast cancer. Previous research has suggested that taking some extra, very thin layers of tissue from around the cancer during the first surgery might help remove all the cancerous cells and reduce the chance of needing a second operation. This study wants to see if this same approach works for DCIS, and also understand how it affects how your breast looks and your experience.

The main aim of this pilot study is to see if we can successfully run a larger study later on. We'll be comparing the standard surgery with this new approach of taking a small amount of extra tissue – about the thickness of a pen. We want to see if this change helps reduce repeat surgeries, how it affects the appearance of your breast, and hear about your experience. Your feedback will be really important in helping us plan a bigger study across the country.

Key takeaways

  • This is a pilot study for women with early breast cancer (DCIS).
  • It tests if removing extra tissue during surgery reduces the need for a second operation.
  • Participation involves random assignment to two surgery groups (standard vs. extra tissue).
  • Looks at cosmetic results, patient experience, and number of second surgeries.
  • May reduce anxiety and delays associated with repeat surgery.
  • Study takes place at St George's Hospital, London.

Who may be eligible?

This study is particularly for women who are between 18 and 90 years old and were born female. You need to have a new diagnosis of a specific type of early breast cancer called Ductal Carcinoma in Situ (DCIS). This should be the first time you've been diagnosed with breast cancer in that particular breast, and you shouldn't have had radiotherapy to that breast before.

You won't be able to join the study if you are male, or if your DCIS is spread out in a way that means you need a mastectomy (full breast removal). Also, if you have difficulty communicating or have had certain previous breast surgeries that would affect the lumpectomy, you wouldn't be eligible. The team will carefully check all these details with you to see if the study is a good fit.

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.

  1. Are you a woman, assigned female at birth?
  2. Are you between 18 and 90 years old?
  3. Do you have a new diagnosis of DCIS only (not other types of cancer)?
  4. Is this your first breast cancer diagnosis in that breast?
  5. Have you NOT had previous radiotherapy to that breast?
  6. Are you able to agree to take part in the study?
Answer every question to see your result.

What does participation involve?

If you are eligible and decide to join, a member of the research team will explain everything and give you time to think. If you agree, you'll sign a consent form. Before your surgery, you'll fill out a questionnaire and have some photos taken of your chest.

On the day of your surgery, you'll have a standard lumpectomy for your DCIS. After this, a computer will randomly place you into one of two groups. You won't know which group you are in. Group A will have the standard surgery with no extra tissue removed. Group B will have a small amount of extra breast tissue removed (called 'cavity shavings') from the edges where the cancer was taken out. Half the people will be in each group. Recovery from surgery is the same for everyone, and most people go home the same day if suitable.

About two weeks after surgery, your results will be discussed, and you'll find out if all the cancer was cleared or if a second operation is needed. You'll also have follow-up appointments. You'll be asked to complete a questionnaire and have more photos taken of your chest at about 4 weeks and then again at one year after your operation.

Potential risks and benefits

Participating in this study comes with potential benefits and risks. If you are in Group B and have the extra tissue removed, it might reduce the chance of needing a second operation, meaning less pain, faster recovery, and less emotional stress. Studies also suggest that avoiding a repeat surgery can lead to better long-term outcomes. However, a possible risk in Group B is that some healthy, cancer-free tissue might be removed unnecessarily, which could slightly change the size or shape of your breast. Remember, you can withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • St George's University Hospital, NHS Foundation Trust
    City only
    London, England

Common questions

What is DCIS?

DCIS stands for Ductal Carcinoma in Situ. It's a very early form of breast cancer where abnormal cells are found in the milk ducts but haven't spread outside of them.

Is the surgery different if I join the study?

You will have a standard lumpectomy. After the lump is removed, you will be randomly assigned to either have no further tissue removed (standard practice) or to have small additional tissue 'shavings' taken from around where the lump was removed.

Will I know which group I'm in?

No, you won't know if you're in the group with or without the extra tissue removal. This helps ensure the study results are fair and unbiased.

What does a 'second operation' mean?

After your first surgery, if the edges of the removed tissue still contain cancer cells, you might need another operation to take out more tissue to ensure all cancer is gone.

How long will I be followed up after my surgery?

You will be asked to complete questionnaires and have photos taken at 4 weeks and 1 year after your operation to check on your recovery and cosmetic outcome.

How to find out more

Sarah Tang

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.