NCT03029065

Brief Summary

This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 20, 2017

Last Update Submit

January 23, 2017

Conditions

Keywords

lung Adenocarcinoma with brain (meningeal) metastasis

Outcome Measures

Primary Outcomes (1)

  • investigate new diagnosis method for lung adenocarcinoma with brain (meningeal) metastasis

    Investigate whether the cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.

    Participants are followed in 6 months after treatment

Study Arms (1)

lung adenocarcinoma with brain (meningeal) metastasis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ages Eligible for Study: 18 Years and older (Adult, Senior) Sexes Eligible for Study: All Accepts Healthy Volunteers: No

You may qualify if:

  • Patients with confirmed diagnosis of lung adenocarcinoma with brain (meningeal) metastasis.
  • Samples collection should be allowed.

You may not qualify if:

  • Pregnant women
  • Minors (subjects less than 18 years of age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wang Y, Luo N, Gao Y, Wu Y, Qin X, Qi Y, Sun T, Tao R, Qi C, Liu B, Yuan S. The joint detection of CEA and ctDNA in cerebrospinal fluid: an auxiliary tool for the diagnosis of leptomeningeal metastases in cancer. J Cancer Res Clin Oncol. 2023 May;149(5):1679-1690. doi: 10.1007/s00432-022-04053-7. Epub 2022 May 18.

Biospecimen

Retention: SAMPLES WITH DNA

Anticoagulated whole blood, anticoagulated cerebrospinal fluid and tumor tissue were collected. DNA was extracted from tumor tissues, genomic DNA was extracted from leukocytes, and cfDNA was extracted from plasma and cerebrospinal fluid.

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yong Wang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shandong Cancer Hospital and Institute

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 24, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

December 1, 2018

Last Updated

January 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share