Trial Outcomes & Findings for Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer (NCT NCT02948751)
NCT ID: NCT02948751
Last Updated: 2024-06-06
Results Overview
Total number of participants with leptomeningeal metastasis detected (ER status)
Recruitment status
COMPLETED
Target enrollment
14 participants
Primary outcome timeframe
6 months
Results posted on
2024-06-06
Participant Flow
Participant milestones
| Measure |
OncoCEE
Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.
OncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Microfluidic Device to Diagnose Leptomeningeal Metastasis in Breast Cancer
Baseline characteristics by cohort
| Measure |
OncoCEE
n=14 Participants
Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.
OncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only includes patients with metastatic breast cancer enrolled with matched samples.
Total number of participants with leptomeningeal metastasis detected (ER status)
Outcome measures
| Measure |
OncoCEE
n=11 Participants
Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.
OncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).
|
|---|---|
|
Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)
Detected by OncoCEE
|
3 Participants
|
|
Total Number of Participants With Leptomeningeal Metastasis Detected (ER Status)
Detected by standard lumbar puncture
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only includes patients with metastatic breast cancer enrolled with matched samples.
Total number of participants with leptomeningeal metastasis detected (HER2 status)
Outcome measures
| Measure |
OncoCEE
n=11 Participants
Patients with breast cancer who are undergoing lumbar puncture for suspicion of leptomeningeal metastasis. An additional CSF sample will be obtained for evaluation of CSF CTCs by OncoCEETM technology and cell-free DNA (recommended amount: 1 tube, 10 mL) at the time of lumbar puncture.
OncoCEE: The CSF sample will be to delivered to Biocept's laboratory for processing, and it will be evaluated for CTCs using OncoCEETM microchannel technology. This CSF sample will also be tested for cell-free circulating tumor DNA (ctDNA).
|
|---|---|
|
Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)
Detected by OncoCEE
|
0 Participants
|
|
Total Number of Participants With Leptomeningeal Metastasis Detected (HER2 Status)
Detected by standard lumbar puncture
|
1 Participants
|
Adverse Events
OncoCEE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place