Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
1. Patients evaluation On all patients a complete clinical history and physical
examination is performed, including routine hematology and biochemistry analyses.
Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is
classified according to WHO criteria at each cycle for each patient. Response is
assessed after two cycles of chemotherapy and every two cycles thereafter, using
Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
2. Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject
and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood
isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing,
etc.
3. Statistical Analysis x2 test is used to summarize the association of response and
adverse events to chemotherapy with genetic polymorphisms.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Response to chemotherapy
Response to chemotherapy is evaluated by Response Evaluation Criteria in Solid Tumors(RESIST).
Response to chemotherapy is evaluated every two cycles of chemotherapy.
Yes
Ningning Dong, PhD
Principal Investigator
Beijing Cancer Hospital
China: Ministry of Health
snp
NCT01199393
August 2010
July 2013
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