NCT06374745

Brief Summary

The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
115mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Jan 2015Dec 2035

Study Start

First participant enrolled

January 2, 2015

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

21 years

First QC Date

April 10, 2024

Last Update Submit

February 6, 2025

Conditions

LymphedemaBreast Cancer

Keywords

Post-surgical TreatmentChronic Lymphedema Treatment

Outcome Measures

Primary Outcomes (21)

  • To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery.

    To design an integrated algorithm for surgical treatment of chronic cancer-associated lymphedema using the following variables captured in Primary Outcomes 2 to 21.

    baseline to follow up (no later than December 2024)

  • Date of follow-up procedure

    Date of follow-up procedure.

    baseline to follow up (no later than December 2024)

  • Follow-up and type of lymphedema surgery

    If applicable, follow-up and type of lymphedema surgery

    baseline to follow up (no later than December 2024)

  • Circumferences of the affected and unaffected side

    Circumferences of the affected and unaffected side preoperatively and at postoperative time points.

    baseline to follow up (no later than December 2024)

  • Postoperative complications

    Postoperative complications

    baseline to follow up (no later than December 2024)

  • Surgery duration.

    Surgery duration in minutes.

    baseline to follow up (no later than December 2024)

  • Type of lymphedema surgery

    Type of lymphedema surgery including number of anastomoses, localization, long-term patency.

    baseline to follow up (no later than December 2024)

  • Date of lymphedema surgery

    Date of lymphedema surgery.

    baseline to follow up (no later than December 2024)

  • Use of compression stockings

    Use of compression stockings

    baseline to follow up (no later than December 2024)

  • Number of lymphedema drainages per week

    Number of lymphedema drainages per week.

    baseline to follow up (no later than December 2024)

  • Stage of lymphedema

    Stage of lymphedema (stage I, II or III)

    baseline to follow up (no later than December 2024)

  • Duration of lymphedema

    Duration of lymphedema.

    baseline to follow up (no later than December 2024)

  • Location of lymphedema

    Location of lymphedema.

    baseline to follow up (no later than December 2024)

  • Subsequent cancer treatment

    Subsequent cancer treatment (Chemotherapy, Radiotherapy)

    baseline to follow up (no later than December 2024)

  • Date of cancer related surgery

    Date of cancer related surgery

    baseline to follow up (no later than December 2024)

  • Tumor staging

    Tumor staging, considering the following parameters: tumor node metastasis (TNM), resection status of the cancerous growth (R), lymphatic vessel invasion by cancerous cells (L), venous invasion by cancerous cells (V) and grade of cancer cells (G).

    baseline to follow up (no later than December 2024)

  • Tumor location

    Tumor location (right, left, both sides).

    baseline to follow up (no later than December 2024)

  • BMI

    Patient's BMI in kg/m2.

    baseline to follow up (no later than December 2024)

  • Comorbidities

    Existence of comorbidities.

    baseline to follow up (no later than December 2024)

  • Age

    Patient's age in years.

    baseline to follow up (no later than December 2024)

  • Gender

    Patient's gender, given the possibilities male or female.

    baseline to follow up (no later than December 2024)

Secondary Outcomes (6)

  • Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema

    baseline to follow up (no later than December 2024)

  • Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer

    baseline to follow up (no later than December 2024)

  • Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history

    baseline to follow up (no later than December 2024)

  • Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history

    baseline to follow up (no later than December 2024)

  • Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS

    baseline to follow up (no later than December 2024)

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lymphedema surgery performed at the University Hospital Basel between 2015 and 2023.

You may qualify if:

  • status post breast cancer or status post another type of cancer or status post no cancer
  • chronic lymphedema - lymphedema lasting over three months - present prior to surgical treatment
  • one type of surgical procedure for treatment of chronic lymphedema or a combination of surgical procedures for treatment of chronic lymphedema was performed
  • one or any combination of the following surgical procedures was used in each individual patient: Lymph Node-Vein Anastomosis (LNVA) , Lymphaticovenous Anastomosis (LVA), Tumescent Liposuction (TL), Vascularized Lymph Node Transfer (VLNT) and/or Water-Assisted Liposuction (WAL)

You may not qualify if:

  • loss to follow-up (data not successfully collected)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elisabeth A Kappos, PD Dr. med

    USB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth A Kappos, PD Dr. med

CONTACT

0041 61 265 25 25elisabeth.kappos@usb.ch

Adriano Fabi, BMed

CONTACT

0041 79 888 12 51adriano.fabi@uzh.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 19, 2024

Study Start

January 2, 2015

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

February 10, 2025

Record last verified: 2025-02

Locations

CH(1)