Clinical trial · Observational
Prognostic Indicators for Radiation-induced Breast Fibrosis
Identifying Prognostic Indicators for the Development of Radiation-induced Breast Fibrosis
NCT05031065CI-TRIAL-00091490terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Loss of Funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women undergoing radiation treatment after lumpectomy for breast cancer.
- description
- There is no specific study intervention being used. Samples will be collected from participants undergoing standard of care radiotherapy at pre-specified timepoints.
- interventionNames
- Radiation: Breast Cancer Radiotherapy
Primary outcomes (4)
- measure
- Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
- timeFrame
- Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
- description
- Measurement of longitudinal changes in plasma ATX in the irradiated breast.
- measure
- Measurement of the ATX-LPA-inflammatory (LPA) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
- timeFrame
- Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf 2. Age 40 and above. 3. Treatment with breast conserving surgery. 4. Intended adjuvant whole breast radiotherapy dose to a dose of 40-42.5 Gy in 15-16 fractions. 5. Luminal A subtype as determined by clinipathologic factors (ER/PR positive, Her-2 negative, low Ki-67 or low OncotypeDx recurrence score Exclusion Criteria: 1. Women who have smoked within the last 5 years 2. Patients requiring adjuvant chemotherapy. 3. Requirement for regional nodal radiotherapy. 4. Requirement for tumour bed boost. 5. Breast implants 6. Patients to be treated with partial breast irradiation. 7. Uncontrolled intercurrent illness or active infection. 8. Patients who have previously received chemotherapy. 9. Patients who have previously received chemotherapy.
References
Publications (0)
Data not yet available
No reference posted for this study.