Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00003830 · OUTCOME

Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence

Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer · Source last updated 2017-12-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage distant disease free at 5 yrs
Interval / dispersion
Not reported
Time frame
From the time of randomization until 5 years

What was measured

Measured at time from randomization to any distant cancer or death to determine percentage of patients distant disease free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.

Analysis population: Data missing or unknown for some patients

Groups in this outcome

Group 1: Negative Node Patients Without Occult Metastases

Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases

Group 2: Negative Node Patients With Occult Metastases

Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group 1: Negative Node Patients Without Occult Metastases3122
Group 2: Negative Node Patients With Occult Metastases584

Reported measurements

Source class 1
Values in percentage distant disease free at 5 yrs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1: Negative Node Patients Without Occult Metastases92.5Not reportedNot reportedNot reportedNot reported
Group 2: Negative Node Patients With Occult Metastases89.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        92.5
      2. group Id
        OG001
        value
        89.7
denoms
  1. counts
    1. group Id
      OG000
      value
      3122
    2. group Id
      OG001
      value
      584
    units
    Participants
description
Measured at time from randomization to any distant cancer or death to determine percentage of patients distant disease free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
groups
  1. description
    Patients with initially negative sentinel node tumors blocks whose tumors, upon re-examination, were not found to have had occult metastases
    id
    OG000
    title
    Group 1: Negative Node Patients Without Occult Metastases
  2. description
    Patients with initially negative sentinel node tumor blocks whose tumors, upon re-examination, were found to have had occult metastases
    id
    OG001
    title
    Group 2: Negative Node Patients With Occult Metastases
param Type
NUMBER
population Description
Data missing or unknown for some patients
reporting Status
POSTED
time Frame
From the time of randomization until 5 years
title
Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence
type
SECONDARY
unit Of Measure
percentage distant disease free at 5 yrs

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice