Clinical Trial: Circulating Tumor DNA in Cerebrospinal Fluid as an Early Biomarker of Leptomeningeal Metastasis (LM)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Tissue and Fluid Collection Pilot Study to Develop Circulating Tumor DNA in Cerebrospinal Fluid as an Early Biomarker of LM in Patients With Metastatic Solid Tumor Cancer
Brief Summary: The purpose of this study is to learn whether the DNA from cancer tumor cells can be found in the cerebral spinal fluid (CSF) that bathes the brain and spinal cord of patients before malignant the cancer cells themselves are able to be found in the CSF. The researchers doing this study hope this information can be used to develop a way to diagnose LM earlier .
Detailed Summary:
Sponsor: Dartmouth-Hitchcock Medical Center
Current Primary Outcome: Tumor DNA detectability and cytological confirmation of leptomeningeal metastasis. [ Time Frame: one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Comparison of circulating tumor DNA levels in CSF with levels in plasma. [ Time Frame: one year ]
- Correlation of circulating tumor DNA levels and patient survival. [ Time Frame: one year ]
- Circulating tumor DNA detection in CSF of patients with cytological evidence of leptomeningeal metastasis. [ Time Frame: one year ]
- Circulating tumor DNA identification in the CSF of patients prior to diagnosis of leptomeningeal metastasis. [ Time Frame: one year ]
- Measurement of circulating tumor DNA levels and cancer cell numbers in CSF following initiation of intrathecal chemotherapy for leptomeningeal metastasis. [ Time Frame: one year ]
Original Secondary Outcome: Same as current
Information By: Dartmouth-Hitchcock Medical Center
Dates:
Date Received: February 21, 2014
Date Started: May 2014
Date Completion:
Last Updated: March 2, 2016
Last Verified: March 2016
