NCT02410603

Brief Summary

The purpose of this study is to explore the detection of circulating tumor DNA, soluble immune markers, and the evaluation of peripheral blood mononuclear cells (PBMC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

April 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

4.1 years

First QC Date

April 2, 2015

Last Update Submit

July 19, 2021

Conditions

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

Keywords

Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • The primary end point is the number and type of mutations detectable in the circulating tumor DNA blood samples.

    1 year

Eligibility Criteria

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

Patients with advanced stage cancer in the thorax who are scheduled to undergo systemic therapy at the Mayo Clinic in Rochester, MN.

You may qualify if:

  • Advanced (non-resectable) malignancy in the thorax
  • Age \>18 years old
  • Willing and able to provide consent
  • No prior history of neoadjuvant therapy

You may not qualify if:

  • Age \<18 years old
  • Unable to provide consent
  • Patients with hemoglobin less than 10 g/dL (to minimize the impact of potential iatrogenic anemia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

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

  • Aaron Mansfield, MD

    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

April 2, 2015

First Posted

April 7, 2015

Study Start

December 1, 2016

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)