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Search / Trial NCT04925089

Localized Leiomyosarcoma Biomarker Protocol

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Jun 11, 2021

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Ct Dna Radiomics Biomarker

ClinConnect Summary

This clinical trial is studying a type of cancer called localized leiomyosarcoma (LMS), which is a rare and aggressive tumor found in soft tissues. The goal of the trial is to better understand how certain markers in the blood and tumor tissue can help predict how well patients respond to chemotherapy. Researchers will collect blood samples before, during, and after treatment to look for circulating tumor DNA (ctDNA), which might indicate how the tumor is responding to the chemotherapy. They will also analyze tumor tissue and images from scans taken during treatment. By following patients for two years after starting the study, the team hopes to find a reliable way to assess the effectiveness of chemotherapy and improve treatment plans for patients at risk of their cancer returning.

To be eligible for this trial, patients must have a specific type of localized LMS that is at least 5 cm in size and can be surgically removed. There are no age restrictions, and both men and women can participate. Participants will receive a combination of chemotherapy drugs called doxorubicin and ifosfamide before surgery. If they have had radiation treatment, it must occur after the chemotherapy. This study is currently recruiting participants and aims to provide valuable insights that could enhance cancer care for patients with this challenging condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with localized leiomyosarcoma (LMS) of extremity, body wall or retroperitoneum
  • Grade 2 or 3, or high-grade LMS
  • Tumor size \>5 cm in greatest dimension
  • Primary tumor amenable to complete resection
  • There is no age requirement
  • Participant agrees to receive neoadjuvant doxorubicin and ifosfamide combination chemotherapy
  • If pre-operative radiation is administered, it must be administered after chemotherapy. Post-operative radiation may be administered
  • Archival tumor tissue (either frozen sample, tissue block containing tumor, or minimum of 4 unstained slides and 1 H\&E stained slide) from diagnostic or pre-treatment biopsy available for study research

About University Of Michigan Rogel Cancer Center

The University of Michigan Rogel Cancer Center is a leading academic research institution dedicated to advancing cancer treatment and prevention through innovative clinical trials. As a National Cancer Institute-designated Comprehensive Cancer Center, it combines cutting-edge research, state-of-the-art facilities, and a multidisciplinary team of experts to deliver personalized care and foster groundbreaking discoveries. The center's commitment to improving patient outcomes is reflected in its robust portfolio of clinical trials, which explore novel therapies and enhance understanding of cancer biology. Through collaboration with patients, researchers, and healthcare professionals, the Rogel Cancer Center aims to translate scientific insights into transformative therapies, ultimately contributing to the global fight against cancer.

Locations

Rochester, Minnesota, United States

Ann Arbor, Michigan, United States

New York, New York, United States

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Scott Schuetze

Principal Investigator

University of Michigan Rogal Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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