Circulating Tumor DNA in Soft Tissue Sarcoma

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03818412
• Other study ID #: DNA-TSAR
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: January 17, 2025

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: Albiruni Razak, M.D.
• Phone: 416-946-2000
• Email: albiruni.razak[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 17, 2025
• Est. primary completion date: December 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Mount Sinai Hospital, Canada, The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification	Duration from time of study trial until end	5 years
Secondary	Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence	Duration from time of study trial until end	5 years