INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 500
- 试验地点
- 6
- 主要终点
- Genomic sequencing of tumor tissue and blood
研究概览
简要总结
This study is being done to identify markers and causes of cancer by analyzing patient's DNA (i.e., genetic material), RNA, plasma, tissues, or other samples that could be informative for patients with cancer. Cancer genetic testing is a series of tests that finds specific changes in cancer cells and normal cells in the body. Researchers may request to access these data as they explore how to better prevent, screen, or treat cancer. This study is also being done to create a biobank (library) of samples and information to learn more about treating cancer. Discovery of genetic variants in patients with cancer could result in opportunities for cancer prevention, earlier diagnosis or better therapy for cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GROUP A: Germline and Somatic Testing
- •Has Mayo Clinic medical record number
- •Confirmed cancer diagnosis
- •Germline and/or somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate)
- •Participant aware of cancer diagnosis
- •Able to provide informed consent
- •≥ 18 years old
- •Ability to provide blood, saliva, bone marrow aspirate or hair follicle sample
- •Ability to provide archived tissue, if somatic testing has not already been completed
- •Note: if tissue unavailable participant may still enroll onto the study for the germline collection, or vice versa, if germline has already been completed may still enroll for somatic tissue/blood testing.
- •GROUP B: Germline testing only:
- •Has Mayo Clinic medical record number
- •Confirmed cancer diagnosis
- •Germline testing has been ordered by the clinical provider (or clinical delegate)
- •Participant aware of cancer diagnosis
- •Able to provide informed consent
- •≥ 18 years old
- •Ability to provide blood, saliva, or hair follicle sample
- •GROUP C: Somatic tumor testing only:
- •Has Mayo Clinic medical record number,
- •Confirmed cancer diagnosis,
- •Somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate)
- •Participant aware of cancer diagnosis,
- •Able to provide informed consent,
- •≥ 18 years old
- •Ability to provide archived tissue or blood for somatic tumor genomic profiling, if not already completed.
- •Group D: Clinical standard of care germline testing via genetic counselor:
- •Has Mayo Clinic medical record number,
- •Standard of care clinical visit with genetic counselor
- •Confirmed cancer diagnosis,
- •Germline testing has been ordered by the clinical provider (or clinical delegate)
- •Participant aware of cancer diagnosis,
- •Able to provide informed consent,
- •≥ 18 years old
- •Ability to provide blood, saliva, or hair follicle sample
- •Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810:
- •Enrolled in any of the following studies: IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810
- •Completed Riskguard, OncoExtra, Caris Assure, or Caris MI Profile or any combination of these tests.
- •Has Mayo Clinic medical record number,
- •Confirmed cancer diagnosis,
- •Participant aware of cancer diagnosis
- •Able to provide informed consent,
- •≥ 18 years old
排除标准
- •Note: Women who are pregnant or planning to become pregnant can take part in this study.
- •GROUP A: Germline and Somatic testing
- •Individuals who have situations that would limit compliance with the study requirements
- •Institutionalized (i.e. Federal Medical Prison)
- •GROUP B: Germline testing only
- •Individuals who have situations that would limit compliance with the study requirements
- •Institutionalized (i.e. Federal Medical Prison)
- •Prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment
- •Group C: Somatic tumor testing only:
- •Individuals who have situations that would limit compliance with the study requirements,
- •Institutionalized (i.e. Federal Medical Prison),
- •Group D: Clinical standard of care germline testing via genetic counselor:
- •Individuals who have situations that would limit compliance with the study requirements,
- •Institutionalized (i.e. Federal Medical Prison)
- •Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810:
- •Individuals who have situations that would limit compliance with the study requirements,
- •Institutionalized (i.e. Federal Medical Prison)
研究组 & 干预措施
Group A: Germline and Somatic Testing
Potential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made.
干预措施: Pan-genomic Testing (Genetic)
Group B: Germline Testing Only
Potential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made.
干预措施: Pan-genomic Testing (Genetic)
结局指标
主要结局
Genomic sequencing of tumor tissue and blood
时间窗: Baseline; 50 years
Genomic sequencing of tumor tissue and blood will be performed to determine genomic alterations in germline and somatic cancer-related genes (SNVs, indels, CNVs from DNA and fusions from RNA) to allow the ordering hematologist/oncologist/provider to determine optimal therapy and clinical trial prospective. Researchers across the field of genomic sequencing report findings about new variations in scientific publications and collect it in databases every day. Consequently, any patient's variant of uncertain significance (VUS) result could be reclassified by emerging findings, turning previously unresolved tests into diagnostic answers. Our Translational Omics Program has a system to re-analyze a patient's exome/genome data against these new genetic findings-reviewing data and comparing it with emerging clinical genetic data to facilitate diagnoses.
次要结局
未报告次要终点