{
"info": {
"nct_id": "NCT00846482",
"official_title": "Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer",
"inclusion_criteria": "* Histologically confirmed diagnosis of colorectal cancer.\n* ECOG Performance Status 0-2 (Appendix A).\n* Patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting.\n* Consent to donate 4 tubes of PBMC of 7 ml of blood each.\n* Willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria).\n* Adequate organ function as defined as:\n\n * Neutrophil count > 1500/μl\n * Platelets > 75,000/ μl\n * Hemoglobin > 8 g/dl\n * Bilirubin < 2.0 X upper limit of normal\n * Creatinine < 2 mg% or calculated clearance > 40 ml/mt\n* The patient must have signed a consent form approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB\nHealthy volunteers allowed",
"exclusion_criteria": "* No other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment.\n* Pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study.\n* Patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery).\n* Patients with grade 2 neuropathy will not be eligible for the study.\n* The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas. At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
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"identified_line": {
"line": "* Histologically confirmed diagnosis of colorectal cancer.",
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}
}
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},
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"exact_snippets": "Neutrophil count > 1500/μl",
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"exact_snippets": "Neutrophil count > 1500/μl",
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"exact_snippets": "Hemoglobin > 8 g/dl",
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"exact_snippets": "calculated clearance > 40 ml/mt",
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},
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}
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}