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Influence of inflammatory processes during radiotherapy on circulating epithelial tumor cells (CETC) and the formation of tumorspheres, as well as the effect of non-steroidal anti-inflammatory drugs (NSAID) on the growth behavior of tumorspheres

Influence of inflammatory processes during radiotherapy on circulating epithelial tumor cells (CETC) and the formation of tumorspheres, as well as the effect of non-steroidal anti-inflammatory drugs (NSAID) on the growth behavior of tumorspheres

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00011840
Enrollment
100
Registered
2017-04-20
Start date
2016-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C50

Interventions

Group 1: Patients with non-metastatic breast cancer: Determination of CETC from serum (maintrac method) on the first irradiation day, both half of the fractions, on the last irradiation day, and 6 wee

Sponsors

Transfusionsmedizinisches Zentrum Bayreuth, Labor Dr. Pachmann Bayreuth
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: • histologically confirmed invasive breast carcinoma • age >= 18 years • exclusive treatment at the Jena University Hospital • Complete curative-intended adjuvant or definite radiotherapy (achieved total dose = 50 Gy normo- or hypofraction) • at least 3 blood samples (before the start of therapy, half of the fractions, after the end of RT, 6 weeks after the end of RT) • Dose concepts: Hypofraction up to 42.56 (2.66) Gy, normofraction to 50.0 (2.0) Gy followed by a boost up to 16.0 Gy, 5 Fx / week

Exclusion criteria

Exclusion criteria: • Lack of willingness to consent • Presence of metastases • Recurrence • DCIS, inflammatory breast carcinoma • Second malignancy <10 years before diagnosis of breast cancer • Radiation therapy in anamnesis

Design outcomes

Primary

MeasureTime frame
Number of CETCs on the first irradiation day, half of the fractions, on the last irradiation day, and 6 weeks after end of radiation therapy (maintrac), overall survival (follow up on cancer registries after 3 & 5 years) disease-free survival 3 & 5 years)

Secondary

MeasureTime frame
Effect of non-steroidal anti-inflammatory drugs (NSAID) on the growth behavior of tumorspheres

Countries

Germany

Contacts

Public ContactMatthias Mäurer

Klinik für Strahlentherapie und Radioonkologie Jena

matthias.maeurer@med.uni-jena.de03641/934004

Outcome results

None listed

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