NCT01713699

Brief Summary

The purpose of this study is to determine whether the quantitative detection of circulating tumor cells (CTCs) in patients with Epcam expressing tumors can be used compared to standard qualitative method - cytology both in the cerebrospinal fluid of patients, clinically suspected for leptomeningeal metastases.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

October 22, 2012

Last Update Submit

January 19, 2021

Conditions

Meningeal Carcinomatosis

Keywords

CTC, cytology, meningeal carcinomatosis, leptomeningeal metastases

Outcome Measures

Primary Outcomes (1)

  • Determine the sensitivity and specificity of detection of circulating tumor cells (CTCs) in patients with Epcam expressing tumors compared to cytology in the cerebrospinal fluid of patients, clinically suspected for leptomeningeal metastases

    3 months after end of study

Secondary Outcomes (6)

  • - To determine the relationship between the number of CTCs in CSF and the patient's neurological condition and WHO performance score

    3 months after end of study

  • - To determine the change in the CTC number between two sampling points and correlate this with the patient's neurological condition and therapy

    3 months after end of study

  • - To determine the relationships between demographics/tumor status and CTCs number in CSF.

    3 months after end of study

  • - To determine the relationship between the CTC cells in the CSF and the CTCs in the peripheral blood

    3 months after end of study

  • To confirm EPCAM positivity in archived primary tumor tissue and tumorcells in CSF.

    3 months after end of study

  • +1 more secondary outcomes

Study Arms (1)

diagnostic

OTHER

Using extra CSF material received by clinically indicated lumbar punctures to determine the sensitivity and specificity of CTCs in CSF (5ml CSF). Standard material of 5 ml CSF for cytology and 2 ml CSF for cell count and chemistry is being regularly used and processed.

Procedure: lumbar puncture

Interventions

lumbar puncturePROCEDURE
diagnostic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are treated for advanced EpCam positive solid tumors (such as breast cancer, lung cancer, gastrointestinal cancer)
  • Age \>= 18 years;
  • Able and willing to give written informed consent;
  • WHO performance status (0, 1, 2, 3 or 4);
  • Able and willing to undergo lumbar puncture and veni-puncture.

You may not qualify if:

  • Lumbar puncture not clinically / diagnostically indicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dutch Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

Location

Slotervaart Hospital

Amsterdam, 1066EC, Netherlands

Location

Related Publications (1)

  • Milojkovic Kerklaan B, Pluim D, Bol M, Hofland I, Westerga J, van Tinteren H, Beijnen JH, Boogerd W, Schellens JH, Brandsma D. EpCAM-based flow cytometry in cerebrospinal fluid greatly improves diagnostic accuracy of leptomeningeal metastases from epithelial tumors. Neuro Oncol. 2016 Jun;18(6):855-62. doi: 10.1093/neuonc/nov273. Epub 2015 Nov 12.

    PMID: 26566655DERIVED

Related Links

MeSH Terms

Conditions

Meningeal CarcinomatosisNeoplastic Cells, Circulating

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Meningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopsySpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • D. Brandsma, MD, PhD

    NKI-AvL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 25, 2012

Study Start

September 1, 2012

Primary Completion

September 6, 2016

Study Completion

September 19, 2017

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

NL(2)