NCT05703295

Brief Summary

Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 13, 2023

Last Update Submit

January 26, 2023

Conditions

Sentinel Lymph Node Biopsy

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

  • Oncologic safety of sentinel node biopsy in clinically palpable axillary lymph node in breast cancer patients

    Evaluation patients with palpable lymph node with breast cancer by sentinel lymph node biopsy and how to affect on the management of breast cancer.

    baseline

Interventions

BiopsyPROCEDURE

Sentinel lymph node biopsy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to Assuit university hospitals more than 18 years old which candidate to sentinel lymph node biopsy during the time of the study.

You may qualify if:

  • age more than 18 years.
  • fit for surgery.
  • Patients with no previous breast surgery. .

You may not qualify if:

  • patients less than 18 years.
  • patients unfit for surgery .
  • patients with advanced breast cancer.
  • Patients with previous breast surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Dixon JM. Sentinel Lymph Node Biopsy in Breast Cancer Surgery. Ann Surg Oncol. 2016 Oct;23(11):3426-3428. doi: 10.1245/s10434-016-5434-6. Epub 2016 Jul 22. No abstract available.

    PMID: 27448117BACKGROUND

  • Qiu SQ, Zhang GJ, Jansen L, de Vries J, Schroder CP, de Vries EGE, van Dam GM. Evolution in sentinel lymph node biopsy in breast cancer. Crit Rev Oncol Hematol. 2018 Mar;123:83-94. doi: 10.1016/j.critrevonc.2017.09.010. Epub 2017 Sep 20.

    PMID: 29482783BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Mohamed Ibrahim Mohamed

CONTACT

01002844642mohammedibraheem22@yahoo.com

Mostafa Thabet Ahmed, Professor

CONTACT

01002798144mostafaharera@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 30, 2023

Study Start

February 1, 2023

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

January 30, 2023

Record last verified: 2023-01