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Circulating Tumor DNA in Cerebrospinal Fluid as an Early Biomarker of Leptomeningeal Metastasis (LM)

This study is currently recruiting participants.
Verified March 2016 by Dartmouth-Hitchcock Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02071056
First Posted: February 25, 2014
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose
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 .

Condition
Leptomeningeal Metastasis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Tumor DNA detectability and cytological confirmation of leptomeningeal metastasis. [ Time Frame: one year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 22
Study Start Date: May 2014
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
history of visceral cancer

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurology and Medical Oncology clinical practices
Criteria

Inclusion Criteria:

  1. Patient must have a previously diagnosed solid tumor malignancy originating from a visceral organ (i.e., outside of the CNS), and present with signs and/or symptoms consistent with carcinomatous meningitis (headache, vision dysfunction, hearing loss, cranial nerve deficit, cognitive dysfunction, focal weakness or numbness suggestive of cranial neuropathy or radiculopathy, cauda equine syndrome, meningismus, and/or bowel or bladder dysfunction).
  2. Age ≥ 18 years.
  3. Patients will meet accepted standard of care and follow FDA guidance for low molecular weight heparin use prior to lumbar puncture, specifically INR < 1.4 and PT within normal range for DHMC laboratory, and platelet count >50,000. For enoxaparin use, delay of Lumbar puncture to allow at least 12 hours after administration of prophylactic doses, such as those used for prevention of deep vein thrombosis. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin (1 mg/kg twice daily or 1.5 mg/kg once daily). A postprocedure dose of enoxaparin should usually be given no sooner than 4 hours after lumbar puncture. Aspirin and other antiplatelet therapy is permitted without timing constraints prior to or after lumbar puncture.
  4. Patient must consent to provide up to additional CSF (10 mL) and blood (10 mL) when these fluids are drawn as part of clinically indicated procedures.
  5. Patient must consent to permit genetic analysis of their cancer.
  6. Patient capable of giving informed consent.
  7. MRI of clinically symptomatic area (spine and/or brain) and/or head CT within the last 3 months to exclude brain disease that would contraindicate lumbar puncture.

Exclusion Criteria:

  1. Evidence of a CNS mass creating mass‐effect or midline shift such that lumbar puncture is contraindicated.
  2. Previous or current hematological malignancy.
  3. Previous or current primary CNS malignancy.
  4. Prior treatment for CNS metastasis.
  5. Known CNS autoimmune or inflammatory disease (i.e., Multiple Sclerosis, neurosarcoidosis, chronic fungal, rickettsial or bacterial meningitis).
  6. Patient is currently receiving treatment for LM.
  7. Patient was previously diagnosed with LM.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071056


Contacts
Contact: Lara K Ronan, MD Lara.K.Ronan@dartmouth.edu
Contact: cancer research nurse 800-639-6918 cancer.research.nurse@dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Principal Investigator: Lara K Ronan, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Lara K Ronan, MD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02071056     History of Changes
Other Study ID Numbers: D13237
First Submitted: February 21, 2014
First Posted: February 25, 2014
Last Update Posted: March 3, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Neoplasm Metastasis
Meningeal Carcinomatosis
Neoplastic Processes
Neoplasms
Pathologic Processes
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases