NCT02471079

Brief Summary

Rationale: The number of breast cancer (BC) patients at risk for long-term radiation-induced health problems is increasing, as their outcome is improving due to intensified treatment regimens, such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with the highest risk for radiation-induced health problems is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
706

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

May 19, 2015

Last Update Submit

February 26, 2024

Conditions

Breast Cancer

Keywords

Radiation-induced health problemsCardiovascular eventsLung toxicity

Outcome Measures

Primary Outcomes (4)

  • Number of participants with cardiovascular events in relation with the received heart radiation dose

    At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy

  • Number of participants with secondary malignancies in relation with the received radiation dose

    At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy

  • Number of participants with radiation pneumonitis in relation with the received lung radiation dose

    At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy

  • Number of participants with hypothyroidism in relation with the received radiation dose

    At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy

Interventions

RadiotherapyRADIATION

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult, female patients with stage I-III breast cancer, who were treated with breast-sparing surgery followed by radiation treatment.

You may qualify if:

  • Female gender.
  • Treated for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS).
  • Treated with curative breast-conserving surgery followed by radiotherapy of the breast, with or without irradiation of the regional lymph nodes.
  • Start of radiotherapy is between 01-01-2005 and 31-12-2008.
  • Available planning CT scan and dose distribution data of original breast cancer irradiation.

You may not qualify if:

  • Any prior malignancy other than non-melanoma skin cancer or breast cancer.
  • Prior radiotherapy treatments in the thoracic region.
  • Treated with neoadjuvant chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

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

Study Record Dates

First Submitted

May 19, 2015

First Posted

June 15, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

NL(1)