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NCT01407770 · ClinicalTrials.gov registry record

Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer

A clinical trial of Breast Cancer and Pain, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
1,000
Enrollment target
1
Study location

NCT01407770: Completed study of Breast Cancer and Pain, sponsored by Wake Forest University Health Sciences.

NCT01407770 is a study of Breast Cancer and Pain that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 1,000 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01407770, a study of Breast Cancer and Pain, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
1,000 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Radiation therapy may cause skin reactions when patients are exposed to high-energy x rays. Studying the genetic pattern of patients before and after radiation therapy may help doctors prevent toxicity and plan the best treatment. PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin reactions in racial/ethnic groups of patients with breast cancer.

Primary Outcome

The primary endpoint is RT-related skin reactions which for consistency and clarity across the study we will use the term "Early Adverse Skin Reaction" (EASR). Skin reactions will be assessed at 4 time points from the start of radiotherapy through 2 months of the post radiotherapy follow-up period. The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. The primary outcome variable will be the occurrence (or not) of RT-ind

Interventions

  • GENETIC gene expression analysis
  • OTHER laboratory biomarker analysis
  • OTHER flow cytometry
  • GENETIC DNA analysis
  • OTHER enzyme-linked immunosorbent assay

Study Locations (1)

North Carolina

  • Wake Forest University Comprehensive Cancer Center - Winston-Salem

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2011-09-20
Est. Completion 2014-08-26
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT01407770 record still lists

NCT01407770 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (64% lower).

The record links to 7 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which gene expression analysis is the first listed.

NCT01407770 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT01407770 about?

NCT01407770 is a clinical study titled "Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer". RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Radiation therapy may cause skin reactions when patients are exposed to high-energy x rays. Studying the genetic pattern of patients before and after radiation therapy may help doctors prevent toxicity and plan the best treatm...

What is the current status of trial NCT01407770?

This trial is currently completed. The enrollment target is 1,000 participants. The study started on 2011-09-20. Estimated completion is 2014-08-26.

What conditions does trial NCT01407770 study?

This clinical trial studies the following conditions: Breast Cancer, Pain, Fatigue, Radiation Toxicity, Cognitive Ability, General.

What interventions are being tested in trial NCT01407770?

The interventions under investigation include: gene expression analysis (GENETIC), laboratory biomarker analysis (OTHER), flow cytometry (OTHER), DNA analysis (GENETIC), enzyme-linked immunosorbent assay (OTHER).

Who is sponsoring clinical trial NCT01407770?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01407770 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01407770's enrollment target sits among peer trials

1,000 120th of 1224 higher than 1,097 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01407770, the US trial registry maintained by the National Library of Medicine. NCT01407770 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.