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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
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The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.
Primary objective
Secondary objective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer immunotherapy patients - no GI side effect | Cancer immunotherapy patients who do not develop GI side effects. | ||
| Cancer immunotherapy patients - develop GI side effects | Cancer immunotherapy patients who develop GI side effects |
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| Measure | Description | Time Frame |
|---|---|---|
| GI disease activity | To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms. | 12 weeks |
| Biospecimen collection | To collect stool, blood, and colon biopsies and have the ability to identify predictive biomarkers in patients that develop colitis as a result of cancer immunotherapy. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a diagnosis of cancer who have undergone or will be undergoing immunotherapy will be eligible for recruitment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Andrews, BS | Contact | 617-724-2090 | eaandrews@mgh.harvard.edu | |
| Keri Sullivan, BS | Contact | 617-724-5955 | ksullivan79@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Dougan, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Ryan J Sullivan, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Blood and stool samples will be collected.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |