NCT02370303

Brief Summary

The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

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

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2016

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

1.9 years

First QC Date

February 17, 2015

Last Update Submit

March 20, 2018

Conditions

Lung CancerLung NeoplasmsCancer of LungCancer of the LungNeoplasms, LungNeoplasms, PulmonaryPulmonary CancerPulmonary NeoplasmsCarcinoma, Non-small-cell LungAdenocarcinomaSquamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Number and types of mutations in the primary tumor.

    Within 1 year

  • Number and type of mutations detectable in the matched circulating tumor cell samples.

    Within 1 year

Secondary Outcomes (1)

  • Concordance of mutations detected by either method.

    Within 1 year

Eligibility Criteria

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

Patients with a stage IB or above non-small cell lung cancer or metastatic cancer undergoing lung surgery at the Mayo Clinic in Rochester, MN.

You may qualify if:

  • Stage IB and above non-small cell lung cancer or metastatic lung cancer
  • Age \>18 years old
  • Willing and able to consent to study
  • No prior history of neoadjuvant therapy.

You may not qualify if:

  • Age \<18 years old
  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Preoperative blood sample, tumor tissue from lung resection, postoperative blood sample

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinomaCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

  • Dennis Wigle, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 24, 2015

Study Start

August 1, 2014

Primary Completion

July 9, 2016

Study Completion

July 9, 2016

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

US(1)