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Clinical Trial Summary

This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent's Riverside. This may help doctors better understand and/or treat others who have genetic mutations.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the prevalence of genetic mutations in cancer patients seeking care at the Mayo Clinic Cancer Center at St. Vincent's Riverside in Jacksonville, Florida. SECONDARY OBJECTIVES: I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care: Ia. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network [NCCN]) based approach for genetic evaluation. Ib. Determine the percentage of relatives of mutation positive probands undergoing family variant testing within a 3 month window of return of testing results. Ic. Assess patient experience and barriers to care with a genetic service line via survey measures. Id. Develop a biorepository of samples (blood) from cancer patients participating in this protocol. OUTLINE: Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results. ;


Study Design


Related Conditions & MeSH terms

  • Brain Neoplasms
  • Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma
  • Central Nervous System Neoplasms
  • Digestive System Neoplasm
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms
  • Genital Neoplasms, Female
  • Head and Neck Neoplasms
  • Malignant Brain Neoplasm
  • Malignant Central Nervous System Neoplasm
  • Malignant Female Reproductive System Neoplasm
  • Malignant Genitourinary System Neoplasm
  • Malignant Head and Neck Neoplasm
  • Malignant Musculoskeletal Neoplasm
  • Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm of Unknown Primary
  • Neoplasms
  • Neoplasms, Unknown Primary
  • Nervous System Neoplasms
  • Skin Carcinoma

NCT number NCT04456140
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 1
Start date June 29, 2020
Completion date September 21, 2021

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