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This study recruits patient with solid tumor types for sample collection and monitoring. Participants will provide blood and archival tissue samples in order to create a Personalized Cancer Monitoring (PCM) assay. This assay will be used to detect circulating tumor DNA (ctDNA) levels in the blood over time and hopefully contribute to improvements in residual disease detection methods for future patients.
Results from this assay will be provided to participants and providers but providers are not asked to change patient care based on this information.
This study involves collection of tumor tissue (from a standard biopsy and/or surgery) as well as blood samples over time in order to allow the creation of a Personalized Cancer Monitoring (PCM) assay. Additional blood samples are taken throughout the patient's treatment and follow-up period.
Each participant will submit one blood sample when they begin participation in the research study. Participants will be asked to submit follow up samples several times per year (annually, at minimum), with the exact frequency varying by stage and type of cancer. In general, participants will not be asked to come into the clinic more frequently than their already needed clinic visits.
If the cancer-specific mutations identified by the PCM are detected in the blood samples provided as part of the study, this may would suggests that residual cancer may be present. This is an observational study comparing MRD results to standard of care methods and collecting provider and patient perspectives, using surveys. Physicians will be informed of all PCM results in the form of a clinical report. Physicians are not asked to base treatment decisions on these results.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Cancer Monitoring (PCM) | Diagnostic Test | personalized molecular test for solid tumor cancer patients that may detect the presence of circulating tumor DNA (ctDNA) and molecular residual disease (MRD), also known as minimal residual disease |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Through study completion, up to 5 years | |
| Relapse Free Survival | Measured through study completion, assessed yearly up to 3 years |
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Inclusion Criteria
Exclusion Criteria
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This study seeks to enroll patients of all solid tumor types across many clinical sites with emphasis on early stage non-metastatic Colorectal, Non small cell lung cancer, breast, ovarian and bladder cancers.
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| Name | Affiliation | Role |
|---|---|---|
| Ed Esplin, MD, PhD | Invitae Corporation | Study Director |
| Michael Korn | Invitae Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbus Regional Health | Columbus | Indiana | 47201 | United States | ||
| Onslow Radiation |
Invitae may share de-identified information and data generated through the study with third parties, including biopharmaceutical companies and biomedical researchers (e.g. academic), for clinical trials, drug development, and other disease-related research purposes.
Only a subset of Invitae personnel will have access to PHI. The PHI will be stored in a secure location and will only be made available to Invitae personnel involved in the Study. Any academic publication of data analysis from this Study will use de-identified information only.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Samples type to be collected is blood.
| Jacksonville |
| North Carolina |
| 28546 |
| United States |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |