NCT03161821

Brief Summary

The purpose of this study is to identify circulating tumor cells in patients with solid tumors. Quantify and characterize these cells, collect patient information in regards to the patient's cancer. Develop a database and a sample repository where future analysis could be done.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

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

Study Start

First participant enrolled

December 9, 2011

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

9.2 years

First QC Date

May 15, 2017

Last Update Submit

September 27, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Documentation of the Quality of CTCs from Patients with Solid Tumors

    Enumeration of participants' circulating solid tumor cells

    Through study completion, an average of 5 years

  • Documentation of the Characterization of CTCs from Patients with Solid Tumors

    Characterization of participants' circulating solid tumor cells

    Through study completion, an average of 5 years

Interventions

Eligibility Criteria

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

Patients with cancerous solid tumors

You may qualify if:

  • Age ≥ 18 years of age
  • Biopsy proven solid tumor malignancy
  • Seen at UNC Chapel Hill Hospital and Health Care System
  • Consents to abstraction of their medical records
  • Signed an institutional review board (IRB)-approved informed consent document for this protocol

You may not qualify if:

  • \< 18 years of age
  • Dementia, altered mental status, incarceration or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation Oncology Clinic - UNC Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Chera BS, Kumar S, Shen C, Amdur R, Dagan R, Green R, Goldman E, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Blumberg J, Patel S, Thorp B, Weissler M, Yarbrough W, Sheets N, Mendenhall W, Tan XM, Gupta GP. Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer. J Clin Oncol. 2020 Apr 1;38(10):1050-1058. doi: 10.1200/JCO.19.02444. Epub 2020 Feb 4.

Related Links

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Lisa A Carey, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 22, 2017

Study Start

December 9, 2011

Primary Completion

February 16, 2021

Study Completion

February 16, 2021

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations