Status:

COMPLETED

Sensory Morbidity Following Breast Surgery

Lead Sponsor:

Memorial Sloan Kettering Cancer Center

Conditions:

Breast Cancer

Eligibility:

FEMALE

21+ years

Brief Summary

The goal of the study is measure breast sensations after breast surgery. The results of this study will help surgeons better understand breast sensations and may improve the way surgery is done.

Eligibility Criteria

Inclusion

  • The Samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-5 years of enrollment.
  • Patients who have undergone immediate, two-stage expander/implant postmastectomy reconstruction
  • Patients who have undergone immediate, autogenous tissue flap reconstruction following mastectomy
  • Patients who have undergone mastectomy alone
  • Patients at least 21 years of age
  • Patients who completed mastectomy ± immediate post-mastectomy reconstruction at least one year but no longer than five years prior to study entry

Exclusion

  • Patients who have had any of the following:
  • delayed reconstruction (no reconstruction at time of surgery) combined autogenous tissue/implant breast reconstruction, and/or
  • Patients who have a pre-surgical history of complex regional pain syndrome
  • Patients who have had radiation therapy
  • Patients who have had a local recurrence
  • Patients who do not speak the English language (validated translations of key questionnaires are not available).

Key Trial Info

Start Date :

February 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

290 Patients enrolled

Trial Details

Trial ID

NCT00625924

Start Date

February 1 2008

End Date

January 1 2014

Last Update

January 16 2014

Active Locations (1)

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Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065