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Clinical Trial Sequencing Program (CTSP)

An NCI clinical researcher discusses a clinical trial with a prospective patient.

Credit: National Cancer Institute

NCI’s CCG and Division of Cancer Treatment and Diagnosis (DCTD) are engaged in a collaboration named Clinical Trial Sequencing Project (CTSP). This project has launched out of a joint aspiration to promote the use of genomics in NCI-sponsored clinical trials of the National Clinical Trials Network (NCTN). CTSP’s goal is to elucidate the molecular basis of response and resistance to therapies studied. Biospecimens collected from NCI-sponsored NCTN clinical trials will undergo whole genome or whole exome sequencing in conjunction with transcriptome sequencing to identify genomic alterations important to the hypotheses stated in the proposals. The genomic and anonymized clinical data from CTSP will be made publically available in the Genomic Data Commons (GDC) to benefit the cancer research community. The cancer types currently under study are breast cancer, renal cell carcinoma, and diffuse large B-cell lymphoma.

Breast Cancer and TAILORx

Trial Assigning Individualized Options for Treatment (TAILORx) is an NCI-sponsored clinical trial investigating whether some breast cancer patients may be treated effectively without undergoing chemotherapy, and if a gene expression test can help choose the best individualized treatment. CCG’s study of breast cancer tissue from TAILORx aims to illuminate the molecular basis of ER-positive, Her2-negative breast cancer response and recurrence, and to provide vital genomic information about breast cancer treatments and outcomes to the cancer research community.

The trial enrolled over 10,000 women with estrogen receptor-positive (ER-positive), human epidermal growth factor-negative (Her2-negative) breast cancer that had not spread to the lymph nodes. Each patient’s tumor was evaluated with a gene expression test for the probability of cancer recurrence following surgical removal. The trial grouped patients based on the score obtained from the gene expression test, into low, middle, and high chance of recurrence. All patients with a high risk of recurrence received chemotherapy, as did randomly assigned middle-risk patients; low-risk patients received hormone therapy only and were spared chemotherapy. Initial results published in the New England Journal of Medicine indicate that low-risk women fare well when spared chemotherapy and that the gene expression test is a clinically helpful tool for determining the best treatment for individual patients.

ECOG-ACRIN E2805 Trial of Renal Cell Carcinoma

CCG will receive tissue samples of renal cell carcinoma (RCC), the most common kidney cancer in adults, from a recent NCI-sponsored clinical trial that tested the effectiveness of two inhibitors of vascular endothelial growth factor (VEGF) in patients with high-risk, non-metastatic RCC.

Abnormal activity of the VEGF pathway drives RCC by stimulating the development of blood vessels that provide nutrients to the tumor. Inhibition of VEGF has been shown to be effective for the treatment of advanced RCC that has metastasized to other areas of the body. However, patients with high-risk, non-metastatic disease treated with sunitinib or sorafenib, both VEGF inhibitors, received no benefit compared to patients who received a placebo following surgical removal of their tumors.

CCG will analyze approximately 400 tissue samples from the ECOG-ACRIN E2805 trial of sunitinib and sorafenib to learn more about genomic drivers of RCC development, metastasis, and recurrence.

Diffuse Large B Cell Lymphoma Trial

CCG will perform a comprehensive molecular analysis of tissue samples of Diffuse Large B Cell Lymphoma (DLBCL), the most common adult non-Hodgkin lymphoma, from a Phase III clinical trial run by Cancer and Leukemia Group B.

The trial, Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B Cell Lymphoma (NCT00118209) treated 430 DLBCL patients with rituximab, an antibody that targets B cells for destruction, in combination with one of two different chemotherapy regimens. By randomly assigning patients to either R-CHOP or Dose Adjusted-EPOCH-R, the study aims to establish which chemotherapy best complements rituximab in the treatment of DLBCL and to develop a molecular predictor of patient responses.

The goal of CCG’s in-depth analysis of the DNA, RNA, and protein of DLBCL samples from this trial is to bolster the findings with rich molecular data and to add key information, including multi-platform analysis of DLBCL subtypes and predictors of tumor resistance.

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