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PARTial BREast RECONstruction With Chest Wall Perforator Flap

Sponsor: Cambridge University Hospitals NHS Foundation Trust

NCT ID: NCT06728527

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 35 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at partial breast reconstruction using a chest wall perforator flap (CWPF), a type of surgery, in people being treated for breast cancer. It is run by Cambridge University Hospitals NHS Foundation Trust.

Who can take part

  • People having partial breast reconstruction with a chest wall perforator flap (CWPF) for primary breast cancer
  • People having delayed surgery to correct a change in breast shape after earlier breast-conserving surgery (BCS)
  • Each surgeon must have carried out at least 10 CWPF operations, and each hospital centre expects to do at least 10 per year

Who may not be able to

  • People having breast-conserving surgery that moves tissue within the breast (volume displacement)
  • People having a mastectomy, with or without immediate breast reconstruction

What taking part involves

  • • Surgery to partly rebuild the breast using a chest wall perforator flap (CWPF)

Time commitment: Not stated — ask the trial team about visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
Female
Number of participants
1,001
Started
2023-06-01
Last checked
2024-12

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer early stage breast cancer (stage 1-3)
  • • Clinical study - 1,001 participants
  • • The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast cancer early stage breast cancer (stage 1-3)
  • • Female only

Where?

  • • Cambridge - Cambridge University Hospitals NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.

More detail

The Main Outcomes and Measures are: A) Patient Demographics and Tumour characteristics 1. Patient demographics: age, body mass index (BMI), comorbidities 2. Preoperative tumour characteristics and location influencing surgical planning B) Treatment characteristics 1. Surgical: operative data, including flap types and distribution 2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Breast CarcinomaBreast NeoplasmsBreast SurgeryBreast Reconstruction Surgery

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

What the study is looking for

  • ✓Patients undergoing partial breast reconstruction using CWPF for primary breast cancer
  • ✓Delayed correction of breast deformity following previous BCS
  • ✓Each surgeon is to have performed a minimum of 10 CWPFs
  • ✓Each centre anticipates completing a minimum of 10/year

Who cannot take part

  • ✗Patients undergoing volume displacement BCS
  • ✗Patients undergoing mastectomy +/- immediate breast reconstruction
See the full criteria
Inclusion Criteria: * Patients undergoing partial breast reconstruction using CWPF for primary breast cancer * Delayed correction of breast deformity following previous BCS * Each surgeon is to have performed a minimum of 10 CWPFs * Each centre anticipates completing a minimum of 10/year Exclusion Criteria: * Patients undergoing volume displacement BCS * Patients undergoing mastectomy +/- immediate breast reconstruction

Where Is This Study? (1 UK site)

Cambridge University Hospitals NHS Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Amit AgrawalPrincipal Investigator
Amit Agrawal, DM, FRCSsurg+44 1223 216 315amit.agrawal2@nhs.net

How to Get in Touch

Amit Agrawal, DM, FRCS

Sponsor contact

CONTACT

+44 1223 216315 amit.agrawal2@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2024-12