Circulating Tumor DNA in Soft Tissue Sarcoma
Primary Purpose
Soft Tissue Sarcoma
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Archival tumor tissue collection and blood draws
Sponsored by
About this trial
This is an interventional other trial for Soft Tissue Sarcoma focused on measuring Circulating tumor DNA
Eligibility 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.
Sites / Locations
- Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Soft Tissue Sarcoma
Arm Description
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
Outcomes
Primary Outcome Measures
Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification
Secondary Outcome Measures
Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence
Full Information
NCT ID
NCT03818412
First Posted
January 24, 2019
Last Updated
January 8, 2023
Sponsor
University Health Network, Toronto
Collaborators
Mount Sinai Hospital, Canada, The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT03818412
Brief Title
Circulating Tumor DNA in Soft Tissue Sarcoma
Official Title
Circulating Tumor DNA Detection in Soft Tissue Sarcoma (DNA-TSAR)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
January 17, 2024 (Anticipated)
Study Completion Date
January 17, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Mount Sinai Hospital, Canada, The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
Circulating tumor DNA
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Soft Tissue Sarcoma
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Archival tumor tissue collection and blood draws
Intervention Description
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 Measure Information:
Title
Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albiruni Razak, M.D.
Phone
416-946-2000
Email
albiruni.razak@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pernille Pedersen, R.N.
Phone
416-946-4501
Ext
2502
Email
pernille.pederson@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albiruni Razak, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albiruni Razak, M.D.
Phone
416-946-2000
Email
albiruni.razak@uhn.ca
First Name & Middle Initial & Last Name & Degree
Limore Arones, R.N.
Phone
416-946-4501
Ext
2504
Email
limore.arones@uhn.ca
First Name & Middle Initial & Last Name & Degree
Albiruni Razak, M.D.
12. IPD Sharing Statement
Learn more about this trial
Circulating Tumor DNA in Soft Tissue Sarcoma
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