Circulating Tumor DNA in Soft Tissue Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03818412|
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : October 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Procedure: Archival tumor tissue collection and blood draws||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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:
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.
- Number of patients with demonstrable circulating tumor DNA (ctDNA) quantification [ Time Frame: 5 years ]
- Number of patients with demonstrable ctDNA quantification with no pre-op tumor burden, necrosis at surgery, or disease recurrence [ Time Frame: 5 years ]
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
|Contact: Albiruni Razak, M.D.||email@example.com|
|Contact: Pernille Pedersen, R.N.||416-946-4501 ext firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Albiruni Razak, M.D. 416-946-2000 email@example.com|
|Contact: Pernille Pedersen, R.N. 416-946-4501 ext 2502 firstname.lastname@example.org|
|Principal Investigator: Albiruni Razak, M.D.|
|Principal Investigator:||Albiruni Razak, M.D.||Princess Margaret Cancer Centre|