CompletedNot Applicable

Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC

Greece30 participantsStarted 2019-10-11

Plain-language summary

Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment. Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female aged ≥ 18 years of age.
✓. Histological confirmed ER+/HER2- metastatic Breast Cancer prior to beginning a treatment
✓. Life expectancy permits participation to the study.
✓. Available tumor tissue sample for molecular analysis.
✓. Signed informed consent form.

Exclusion criteria

✕. Female younger than 18 years old.
✕. History of another malignancy within 3 years or current 2nd primary malignancy.
✕. Patients that have not signed the informed consent.

What they're measuring

Clinical performance of PIK3CA kit in CTCs, plasma and tumor tissue samples of metastatic breast cancer patients

Timeframe: 18 months

Trial details

NCT IDNCT04480814

SponsorPharmassist Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-02-08

View on ClinicalTrials.gov More Breast Cancer trials