NCT00122239

Brief Summary

This study will examine, for the first time, the independent contribution of a patient's own genetic makeup to the development of post-radiation complications, permitting the future development of predictive tests to avoid radiation injury. To do this, the investigators will examine gene markers in a series of breast, prostate, brain and lung cancer survivors who have received conformal radiotherapy between 1996 and 2003 at the Cross Cancer Institute and Tom Baker Cancer Centre.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

12.1 years

First QC Date

July 20, 2005

Last Update Submit

March 14, 2016

Conditions

Keywords

radiotherapyradiation toxicitysingle nucleotide polymorphismbreast carcinomaprostate carcinomasquamous cell carcinoma of the head and necklung carcinoma (non-small cell)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be selected consecutively if they have undergone a course of radical radiotherapy.

You may qualify if:

  • Breast cancer
  • Prostate cancer
  • Squamous cell carcinoma (SCC) of the head and neck
  • Non-small-cell-lung carcinoma (NSCLC)
  • Glioma treated by radiotherapy

You may not qualify if:

  • Follow-up less than 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsGliomaProstatic NeoplasmsCarcinoma, Squamous CellCarcinoma, Non-Small-Cell LungHead and Neck NeoplasmsRadiation InjuriesSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Squamous CellCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesWounds and Injuries

Study Officials

  • Matthew Parliament, MD

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

January 1, 2005

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations