Circulating Tumor DNA in Soft Tissue Sarcoma

March 20, 2024 updated by: University Health Network, Toronto

Circulating Tumor DNA Detection in Soft Tissue Sarcoma (DNA-TSAR)

This research study will collect blood and tumor tissue samples from patients with soft tissue sarcoma to look at circulating tumor deoxyribonucleic acid (DNA). When tumor cells are damaged or die, DNA from the tumor cells are released into the blood stream as the cells break down. This is called circulating tumor DNA. Circulating tumor DNA is an important biomarker that may be used in cancer detection, prediction of treatment response, and disease monitoring.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Researchers are continually looking for ways to understand the biology of cancer such as sarcoma, and ways to improve cancer care and patient outcome.

Research has shown that changes in some genes and/or proteins, called biomarkers, may be important indicators for certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and functioning of the cells in the body and are passed down from parent to child. RNA is involved with producing proteins in the body. Further research is needed to better understand the changes found in cancer cells and what this means for certain treatments.

Circulating tumor DNA is an important biomarker that may be used in cancer detection, prediction of treatment response and disease monitoring. When tumor cells are damaged or die, DNA from the tumor cells are released into the blood stream as the cells break down. This is called circulating tumor DNA. Researchers are looking for better ways to detect circulating tumor DNA so that it can be studied.

The purpose of this study is to determine how feasible it is to detect circulating tumor DNA in blood samples of soft tissue sarcoma patients and whether there is a connection between circulating tumor DNA and the likelihood of patients' disease coming back after they receive treatment. To do this, blood and tumor tissue samples will be collected from participants and will undergo DNA testing (reading the contents of their DNA, called sequencing). The results of the DNA testing in the blood samples will be compared with the results from DNA testing that will also be done on tumor tissue. The results will also be compared with participant's response to their treatment, recurrence, and/or long term survival.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Albiruni Razak, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have histologically confirmed high-risk extremity or retroperitoneal liposarcoma, leiomyosarcoma and undifferentiated pleomorphic sarcoma.
  • Patients must have archival tissue from the diagnostic biopsy available.
  • Deemed appropriate for preoperative or postoperative radiotherapy and curative surgery following patient assessment by radiation oncologist and surgical oncologist.
  • Age 18 years or older.
  • Eastern Cooperative Group (ECOG) performance status ≤ 2
  • Ability to understand and willing to sign a written informed consent document and comply with study requirements.

Exclusion Criteria:

  • Patients with benign histology
  • Patients with prior malignancy within previous 5 years or concurrent malignancy other than adequately treated basal cell carcinoma of skin or carcinoma in-situ of cervix.
  • Patients with planned neo-adjuvant chemotherapy.
  • Patients with regional nodal disease or unequivocal metastases
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soft Tissue Sarcoma

A sample of archival tumor tissue will be collected.

Blood samples (about 20-30 mL or 1-2 tablespoons each sample) will be taken:

  • Prior to planned radiation treatment
  • 2-4 weeks after cancer surgery
  • Every 12 weeks after surgery for up to 2 years
Procedure: Archival tumor tissue collection and blood draws
Archival tumor tissue will be collected for testing of circulating tumor DNA. Blood draws will be taken for testing of circulating tumor DNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification
Time Frame: 5 years
Duration from time of study trial until end
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence
Time Frame: 5 years
Duration from time of study trial until end
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

The Hospital for Sick Children
Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Albiruni Razak, M.D., Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2019

Primary Completion (Estimated)

December 17, 2024

Study Completion (Estimated)

January 17, 2025

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNA-TSAR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Soft Tissue Sarcoma

Clinical Trials on Archival tumor tissue collection and blood draws

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe