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Trial record 5 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

Evaluation Of Lymph Nodes After Neoadjuvant Chemotherapy

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified April 2016 by Ranja Sharma, Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Ranja Sharma, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02752009
First received: April 22, 2016
Last updated: April 22, 2016
Last verified: April 2016
  Purpose
This research protocol is studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).

Condition Intervention
Breast Cancer Procedure: Axillary Lymph Node Sampling Clip

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation Of Axillary Lymph Node Metastases With Sentinel Lymph Node Biopsy After Neoadjuvant Therapy In Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Ranja Sharma, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • False Negative Rate (FNR) Of Sentinel Lymph Node Biopsy At The Time Of Surgery [ Time Frame: 2 years ]

Estimated Enrollment: 75
Study Start Date: June 2016
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Axillary Lymph Node Sampling Clip
  • Axillary Lymph Node Biopsy

    -- Axillary lymph node sampling with clip placement into the sampled lymph node. After the tissue sampling of any suspicious nodes, a marker clip will be placed to allow for intra-operative identification of the biopsied nodes.

  • Neoadjuvant therapy at the discretion of the treating Medical Oncologist. Once Neoadjuvant therapy is completed, surgery in the form of either Lumpectomy or Mastectomy is performed.

    • Wire-localization of the clipped node on the day of surgery.
    • Lymphatic mapping performed with either radiocolloid and/or blue dye.
    • Sentinel lymph node biopsy will be performed on the day of surgery.

      --- If the clipped node which contains the wire is not part of this sentinel lymph node specimen, then it will be removed separately and be sent to Pathology as a separate specimen.

    • Axillary lymph node dissection as is the standard of care.
Procedure: Axillary Lymph Node Sampling Clip

Detailed Description:
  • This research study is a Pilot Study, which is the first time investigators are examining this study intervention locally; although this intervention has been studied nationally in published clinical trials.
  • In this research study, the investigators are studying the accuracy of the sentinel lymph node biopsy procedure in breast cancer patients who have cancer cells in the lymph nodes in the armpit (axilla) who have received chemotherapy or endocrine therapy prior to having surgery (neoadjuvant therapy).
  • A sentinel lymph node biopsy is a surgical evaluation of the lymph nodes in the underarm area in patients who have early breast cancer. Approximately, two-five nodes are removed from the underarm area for evaluation. The sentinel lymph node biopsy is performed in patients with breast cancer to determine if there are cancer cells in the lymph nodes in the armpit.
  • The sentinel lymph node biopsy procedure is performed by injecting one or two dyes into the breast, which then travel to the armpit region via small vessels in the immune system. These nodes are called the sentinel lymph nodes. They represent the first nodes that drain the breast tissue. They are closely evaluated by a Pathologist to determine if cancer cells are present.
  • This information allows physicians to know how far the cancer may have spread and recommend therapies accordingly.
  • If sentinel lymph node biopsy is determined to be accurate in patients who are known to already have cancer cells in the axillary lymph nodes who receive neoadjuvant therapy, then in the future, many of the patients in this population may be spared the procedure of a full axillary lymph node dissection, which removes a larger number of lymph nodes and thus has increased risks and side-effects.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients will include any patients with biopsy-proven breast cancer and biopsy-proven axillary lymph node metastases at Beth Israel Deaconess Medical Center who are candidates for Neoadjuvant Chemotherapy or Neoadjuvant Endocrine therapy.
  • A core needle biopsy or fine needle aspiration is acceptable for diagnosis of metastatic disease in lymph nodes.
  • Patients will be identified as possible participants in the Radiology Imaging suites and Breast Surgery Clinics.

Exclusion Criteria:

-Patients with inflammatory breast cancer or distant metastases will be excluded from participating in this study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02752009

Contacts
Contact: Ranjna Sharma, MD 617-667-8807 Rsharma1@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Ranjna Sharma, MD    617-667-8807    Rsharma1@bidmc.harvard.edu   
Principal Investigator: Ranjna Sharma, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Ranjna Sharma, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Ranja Sharma, Ranjna Sharma, M.D, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02752009     History of Changes
Other Study ID Numbers: 15-494
Study First Received: April 22, 2016
Last Updated: April 22, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Ranja Sharma, Dana-Farber Cancer Institute:
Breast Cancer
Armpit lymph nodes Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 23, 2017