Neoplasms

All Conditions

Rare Diseases

Leiomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Blood and tissue will be collected and analyzed for detection of ctDNA and genetic change

Blood and Tissue collection

Scott Schuetze

Scott Schuetze, MD/PhD

Brittany Siontis, MD

Sujana Movva, MD

Elizabeth J Davis, MD

* Leiomyosarcoma (LMS) is one of the more common soft tissue sarcomas (STS).
* Patients presenting with large, high-grade, localized LMS are at significant risk of developing metastasis following curative surgery.
* Clinical trials of neoadjuvant or adjuvant anthracycline and ifosfamide have suggested that patients with localized STS who are at high-risk of metastasis may benefit from chemotherapy, but the magnitude of benefit in unselected patient population is relatively small.
* Currently, patient age, and tumor size and grade are used to assess risk of metastases and survival
* Studies evaluating tumor response by imaging and histopathology have not established correlation between tumor characteristics as biomarkers for risk of metastasis or sarcoma recurrence.
* Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic LMS and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to, during and after chemotherapy and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Patients will be followed for 2 years after study entry for signs of sarcoma recurrence.
* A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning.

Blood will be obtained after enrollment for analysis of germ-line DNA and for ctDNA. Archival tissue will be collected and analyzed for gene mutations in leiomyosarcoma. Tumor tissue from sarcoma resection will be collected and analyzed for genetic changes in leiomyosarcoma after treatment. Digital Images will be collected and analyzed for change in imaging characteristics.

Localized Leiomyosarcoma Biomarker Protocol

Pilot Study of ctDNA and Imaging Characteristics as Biomarkers of Disease-related Outcomes in Patients With Localized Leiomyosarcoma Receiving Chemotherapy

We will share deidentified genetic data on the NIH site, and deidentified imaging data will be shared with the lab at Columbia University. We are not sharing patient identities.

Tumor characteristics from imaging will be compared to the presence of circulating tumor DNA , obtained from blood samples over multiple time points

Blood will be collected at multiple timepoints. The presence of ctDNA will be assessed prior to, during, and after treatment with chemotherapy and / or radiation

The change in the presence of ctDNA from serial blood collection will be compared to the absence of sarcoma recurrence or after 2 years

National Cancer Institute (NCI)

University of Michigan Rogel Cancer Center

Symptoms and General Pathology

Digestive System Diseases

Recurrence

Esophageal Neoplasms

Disease Attributes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Blood DNA will be isolated from plasma. Tumor DNA will be purified with a kit and amplified regions of 10 genes discovered to by mutated in whole exome sequencing.

Blood and Tissue Collection

Shanda Blackmon, MD, MPH

To prospectively collect blood and tumor tissue from esophageal cancer patients to identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.

Esophageal carcinoma is an aggressive malignancy and about a third of patients present with distant metastatic disease. While survival is slowly improving with better diagnostic tools and therapy, the overall 5-year survival remains low at 18%. Unlike other malignancies, such as colon cancer and prostate cancer, there is no peripheral blood marker of response or recurrence during treatment in esophageal cancer. However, quantifying cfDNA is a unique and tumor specific avenue that may allow real time response to treatment in esophageal cancer.

To identify esophageal cancer specific mutations, tumor samples will undergo whole exome sequencing. From this data, the investigators will select 10-15 genes to focus their efforts. PCR primers will be designed to detect these tumor specific mutations in the cell-free component of peripheral blood samples over the course of treatment for esophageal cancer.

The investigators will obtain baseline blood (before treatment) and then collect blood after neoadjuvant treatment, after surgery, and then at subsequent visits from the participants.

Patients will have blood drawn prior to any neoadjuvant treatment or surgery. Tumor tissue will be collected and stored after pathologic evaluation has been completed. Blood collections will then be drawn at every subsequent follow up visit at Mayo Clinic for surveillance.

Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence

To identify specific esophageal cancer mutations that can be measured in the blood (cell free DNA) during the course of treatment as a marker of response and recurrence.

To validate cfDNA as a marker of recurrence of esophageal cancer.

Mayo Clinic

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Pt will be asked to undergo a research core needle biopsy of the primary tumor. If pts are not agreeable to a research biopsy then the original diagnostic biopsy material will be requested. They will also undergo a diagnostic biopsy of a metastatic site, if not already performed, and a blood draw as appropriate for correlative science studies. Additionally, patients will complete a general medical questions form at the time of enrollment.

A blood sample will be collected and patients will complete a general medical questions form at the time of enrollment. Paraffin tissue from the prior surgical procedure will be obtained as Tissue sample. Paraffin tissue from the diagnostic biopsy of a metastatic site will also be obtained. In the event that fresh frozen tissue is available for either site this will also be requested.

Monica Morrow, MD

The purpose of this study is to study patients presenting with stage IV breast cancer. Stage IV means that the breast cancer has spread to another part of the body outside the breast. This study is important because in different parts of the country some patients are being offered surgical treatment for the breast tumor and some are not. The doctors do not know if surgery for the breast tumor is helpful in patients with stage IV breast cancer. The doctors will collect information about the patient and their treatment to learn more about how patients and doctors make treatment decisions. The doctor will also collect blood samples and tissue samples for laboratory studies to learn more about tumors that have spread to other parts of the body.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Localized Leiomyosarcoma Biomarker Protocol	NCT04925089	Leiomyosarcoma	Blood and Tissu...	-	University of Michigan Rogel Cancer Center
Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence	NCT03108885	Esophageal Neop... Esophageal Neop... Esophageal Neop... Cancer of Esoph... Cancer of the E... Esophageal Canc... Esophagus Cance... Neoplasm, Esoph...	Blood and Tissu...	19 Years -	Mayo Clinic
Localized Leiomyosarcoma Biomarker Protocol	NCT04925089	Leiomyosarcoma	Blood and Tissu...	-	University of Michigan Rogel Cancer Center
Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer	NCT00941759	Breast Cancer		18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for blood and tissue collection