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Circulating MicroRNA as Biomarker of Cardiotoxicity in Breast Cancer

W

West Pomeranian Cancer Center

Status

Completed

Conditions

Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT02065908
ZCO-2014-BD

Details and patient eligibility

About

In the proposed project the investigators will asses whether changes in expression of selected circulating microRNAs in serum could comprise a sensitive and specific biomarker of cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.

Full description

Blood will be taken

  1. before anthracycline based chemotherapy administration
  2. at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion)
  3. after anthracycline chemotherapy cessation
  4. 6 months after chemotherapy cessation if an end point occurs
  5. 12 months after chemotherapy cessation if an end point occurs

Echocardiography will be performed

  1. before anthracycline based chemotherapy administration
  2. after anthracycline based chemotherapy cessation
  3. 6 months after anthracycline based chemotherapy cessation
  4. 12 months after anthracycline based chemotherapy cessation if no end point was observed earlier The investigators will perform high-throughput miRNA(microRNA) expression profiling of serum samples - called training set.

Training set will consist of sera of 30 patients who has reached an end point. Training set will be sequenced using next generation sequencing.

Training set will be used to derive a miRNA signature capable of separating early cardiotoxicity patients from healthy ones. MiRNA signature will be validated using validation set.

Enrollment

128 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age 18-70
  • stage I-III TNM (Tumor Node Metastases)

Exclusion criteria

  • second or next cancer (except for basal cell skin cancer and CIN)
  • previously treated with chemotherapy
  • previously treated with radiotherapy
  • acute myocardial infarction
  • heart failure
  • cardiomyopathy

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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