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| ID | Type | Description | Link |
|---|---|---|---|
| LCI-SAR-BSTS-CTDNA-001 | Other Identifier | Atrium Health |
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| Name | Class |
|---|---|
| Paula Takacs Foundation | UNKNOWN |
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The purpose of this research study is to see how well Low Pass Whole Genome Sequencing (LP-WGS) can detect circulating tumor deoxyribonucleic acid (ctDNA) in the blood of participants who have bone or soft tissue sarcoma (type of cancer).
In this ever-expanding age of precision oncology, the stagnant treatment algorithms and subsequent oncologic outcomes for sarcoma patients highlight the need for novel technologies to help clinicians treat these patients. While countless prognostic and therapeutic molecular biomarkers have been identified for many other cancers, sarcoma practitioners have strikingly few tumor markers to guide treatment. The development of a sarcoma-specific liquid biopsy could greatly help clinicians with diagnosis, prognostication, treatment response, minimal recurrent disease, and recurrence. The purpose of this study is to clinically evaluate ctDNA liquid biopsy approaches in adult and pediatric patients with bone and soft tissue sarcomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Metastatic and Resectable | Cohort A1: Non-metastatic/ Resectable (with planned or you are undergoing therapy)- your cancer has not spread, may be able to remove it with operation |
| |
| Metastatic and Un-resectable | Cohort A2: Metastatic/ Unresectable (with planned or you are undergoing therapy)- your cancer has spread, not able to operate at this time to take out all the cancer |
| |
| No evidence of disease, under surveillance | Cohort B: No evidence of disease/ surveillance (you have completed initial therapy)- currently there is no evidence of your cancer/disease and you are under surveillance, meaning your physician is checking your medical situation at intervals or occasionally for any sign of changes |
| |
| ALT or WDLS | Cohort C: You have been diagnosed with ALT (atypical lipoma) or WDLS (well-differentiated liposarcoma) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Metastatic and Resectable | Other | Blood Draw Timepoints:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with ctDNA detected | A binary variable indicating whether or not ctDNA was detected by low pass whole genome sequencing (LP-WGS) in the sample. | Approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of ctDNA detected | A longitudinal continuous variable indicating the quantitative levels of ctDNA in the sample as measured by LP-WGS. Timepoints include pre-treatment, at disease evaluations during treatment, post-treatment, at remission/complete response (if applicable), during surveillance (if applicable), and at recurrence/progression (if applicable) | Approximately 24 months |
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Inclusion Criteria:
Written informed consent or assent when applicable from the participant, LAR, parent or legal guardian and HIPAA authorization for release of personal health information.
All ages allowed
Suspected or confirmed disease (must meet one of the criteria below):
Suspected bone or soft tissue tumor concerning for sarcoma (pending confirmation of sarcoma diagnosis)
OR
Suspected lipomatous mass concerning for ALT or WDLS with planned surgery
OR
Confirmed bone or soft tissue sarcoma meeting one of the criteria below:
Exclusion Criteria:
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Patients of all ages with concern for or diagnosed with bone or soft tissue sarcoma or lipomatous mass will be identified by treatment investigators in oncology clinics treatment patients with sarcoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meg Lattanze | Contact | 980-442-4239 | Megan.Lattanze@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Johann Hsu, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000410 | Alanine Transaminase |
| ID | Term |
|---|---|
| D000637 | Transaminases |
| D019884 | Nitrogenous Group Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
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Blood specimen
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| Metastatic and Un-resectable | Other | Blood Draw Timepoints:
|
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| No evidence of disease, under surveillance | Other | Blood Draw Timepoints:
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| ALT or WDLS | Other | Blood Draw Timepoints: • Collect once after surgery (up to six weeks after surgery) |
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| Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
|
| D045762 |
| Enzymes and Coenzymes |