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TGFB-1 level in breast cancer patients treated with external beam whole breast irradiation versus accelerated partial breast irradiation

The comparison of transforming growth factor beta-1 serum levels in early-stage breast cancer patients treated with external beam whole breast irradiation plus boost versus interstitial brachytherapy accelerated partial breast irradiation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211212053368N1
Enrollment
20
Registered
2021-12-20
Start date
2021-12-22
Completion date
Unknown
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer. Malignant neoplasm of unspecified site of unspecified female breast

Interventions

Intervention 1: Intervention group: external irradiation of the whole breast plus boost (photon or electron) is performed. The prescribed dose to isocenter will be 42.5 Gray in 16 fractions or 50 Gray

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: Age more than 45 years Unifocal and unicenric breast cancer less than or equal to 3 cm in size (including various histologies of invasive ductal, Papillary, mucinous, tubular, edullary and lobular carcinoma and low to moderate risk intraductal carcinoma) No invasion to the lymphovascular space No lymphatic involvement in invasive histologies No distant metastasis Consent to participate in the study

Exclusion criteria

Exclusion criteria: Extensive Intraductal Component (EIC) in breast imaging evaluation Paget disease of the breast or skin involvement Synchronous tumor or history of breast cancer History of malignancy 5 years before enrollment Pregnancy or lactation History of collagen vascular disease, or genetic diseases such as ataxia Telangiectasia that leads to increased radiation sensitivity

Design outcomes

Primary

MeasureTime frame
Serum level of Transforming Growth Factor Beta-1 (TGFB-1). Timepoint: Before radiotherapy, immediately after the end of radiotherapy and three months after the end of radiotherapy. Method of measurement: Assessment of serum levels of TGF-beta1 by Enzyme-linked immunosorbent assay technique (ELISA).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarjan Kouhzad Mohammadi

Ahvaz University of Medical Sciences

Marjankouhzad@gmail.com+98 61 3001 3374

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026