NCT05031065

Brief Summary

To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
terminated

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

August 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 24, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

August 25, 2021

Last Update Submit

June 24, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

  • Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.

    Measurement of longitudinal changes in plasma ATX in the irradiated breast.

    Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.

  • Measurement of the ATX-LPA-inflammatory (LPA) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.

    Measurement of longitudinal changes in plasma LPA in the irradiated breast.

    Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.

  • Measurement of the ATX-LPA-inflammatory (cytokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.

    Measurement of longitudinal changes in plasma cytokines in the irradiated breast.

    Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.

  • Measurement of the ATX-LPA-inflammatory (chemokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.

    Measurement of longitudinal changes in plasma chemokines in the irradiated breast.

    Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.

Secondary Outcomes (3)

  • Structural changes in the irradiated breast and the non-irradiated breast

    3, 6, 12, 24 and 48 months after RT

  • Acute Radiotherapy Toxicity

    Throughout the duration of the study, a total of 4 years .

  • Relationship with Cytomegalovirus infection

    Seropositivity for CMV will be checked only at baseline.

Study Arms (1)

Women undergoing radiation treatment after lumpectomy for breast cancer.

There is no specific study intervention being used. Samples will be collected from participants undergoing standard of care radiotherapy at pre-specified timepoints.

Radiation: Breast Cancer Radiotherapy

Interventions

Breast Cancer RadiotherapyRADIATION

4000-4250 cGy in 15-16 daily fractions

Women undergoing radiation treatment after lumpectomy for breast cancer.

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBorn as genetic females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will study a low risk group of 27 post-menopausal patients with luminal A breast cancer after they have received breast conserving surgery (lumpectomy). Women who have smoked or received chemotherapy will be excluded to minimize variables.

You may qualify if:

  • Female participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
  • Age 40 and above.
  • Treatment with breast conserving surgery.
  • Intended adjuvant whole breast radiotherapy dose to a dose of 40-42.5 Gy in 15-16 fractions.
  • Luminal A subtype as determined by clinipathologic factors (ER/PR positive, Her-2 negative, low Ki-67 or low OncotypeDx recurrence score

You may not qualify if:

  • Women who have smoked within the last 5 years
  • Patients requiring adjuvant chemotherapy.
  • Requirement for regional nodal radiotherapy.
  • Requirement for tumour bed boost.
  • Breast implants
  • Patients to be treated with partial breast irradiation.
  • Uncontrolled intercurrent illness or active infection.
  • Patients who have previously received chemotherapy.
  • Patients who have previously received chemotherapy.

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 Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zsolt Gabos, MD

    AHS-CCI

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 1, 2021

Study Start

January 24, 2024

Primary Completion

May 5, 2025

Study Completion

May 5, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations

CA(1)