CClinicalTrials.gg
Sign In
CompletedNCT03302325Updated Sep 19, 2024

Circulating Tumor DNA As Liquid Biopsy in Patients with Stage IV Solid Tumors, a Feasibility Study At MUSC HCC

An observational study in Solid Tumor, Adult, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Medical University of South Carolina · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

  1. To demonstrate the ability to detect specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.
  2. To compare, in each patient, ctDNA longitudinal samples through treatment, and when available, with those of primary tumor and metastasis.
Read the detailed description

The overall goal of this study is to study circulating tumor DNA (ctDNA) in the blood to determine how cancer cells in patients react to treatment. DNA is short for deoxyribonucleic acid. DNA contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. This reaction will be measured by studying patient blood that will be collected before and during treatment until there is disease progression.

02

Conditions studied

  • Solid Tumor, Adult

Browse trials for

Keywords

  • stage IV solid tumor
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with stage IV cancer that start a new line of treatment and agree to have blood drawn

Inclusion criteria

  • Confirmed diagnosis of stage IV malignancy, including any advanced solid tumors (including lymphoma)
  • Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-3
  • Life expectancy ≥ 3 months
  • Patients must be able to provide consent
  • Patients can be enrolled in other interventional clinical trials

Exclusion criteria

Exclusion Criteria:

  • Age \< 18-year-old
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Stage IV solid tumors

    adult patients with stage IV cancer that are starting a new line of treatment

    Procedure: research blood draws

Interventions

  • Procedureresearch blood draws

    Twenty-five mL of peripheral blood (PB) will be collected for research. Blood will be collected in EDTA tubes and used to isolate ctDNA. For each subject we will request that he/she contribute 25 mL of plasma no more frequently than every 6 weeks, and at same time of standard of care blood draws and routine clinic visit, and for no more than 3 times (including baseline and end of study).

05

What researchers measure

Primary outcomes

  1. Detecting specific cancer mutations in ctDNA isolated from plasma of stage IV cancer patients at HCC.

    Time frame: 24 months

  2. Changes in patients' ctDNA longitudinal samples through treatment, and when available, of primary tumor and metastasis.

    Time frame: 24 months

06

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
07

Registry details

Key details

Study ID
NCT03302325
Lead sponsor
Medical University of South Carolina
Responsible party
Sponsor
First posted
Oct 5, 2017
Start date
Oct 12, 2017
Primary completion
Jan 6, 2020
Completion
Jan 6, 2020
Last update
Sep 19, 2024

Study contacts

Antonio Giordano, MD
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Medical University of South Carolina

Start the discussion