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Circulating Tumor DNA in Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT03818412
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Collaborators:
Mount Sinai Hospital, Canada
The Hospital for Sick Children
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Procedure: Archival tumor tissue collection and blood draws Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Circulating Tumor DNA Detection in Soft Tissue Sarcoma (DNA-TSAR)
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : January 17, 2024
Estimated Study Completion Date : January 17, 2025

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818412


Contacts
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Contact: Albiruni Razak, M.D. 416-946-2000 albiruni.razak@uhn.ca
Contact: Pernille Pedersen, R.N. 416-946-4501 ext 2502 pernille.pederson@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Albiruni Razak, M.D.    416-946-2000    albiruni.razak@uhn.ca   
Contact: Pernille Pedersen, R.N.    416-946-4501 ext 2502    pernille.pederson@uhn.ca   
Principal Investigator: Albiruni Razak, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Mount Sinai Hospital, Canada
The Hospital for Sick Children
Investigators
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Principal Investigator: Albiruni Razak, M.D. Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03818412    
Other Study ID Numbers: DNA-TSAR
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Circulating tumor DNA
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms