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Pipeline Reprioritization
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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Biomarker Screening Protocol for Preliminary Eligibility Determination for Adoptive T-cell Therapy Trials:This is a decentralized, multi-site, US-based biomarker screening study to identify participants who have specific disease indications and tumor expression of target(s) of interest that may inform eligibility for active and future Lyell clinical trials. No investigational treatments will be administered in this non-interventional screening study. Only previously obtained archival tumor tissue will be allowed on this study for biomarker analysis. Fresh tumor biopsies are not permitted on this study. The study will be conducted virtually and participants will utilize telehealth and e-consent modules. If participants tumors express the biomarkers of interest they can be referred to open and enrolling clinical trials. Participation on the screening study does not guarantee enrollment or treatment on an interventional clinical trial.
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| Measure | Description | Time Frame |
|---|---|---|
| To identify participants whose tumors express biomarkers, such as ROR1, that may inform eligibility for active and future Lyell clinical trials | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To explore tumor expression of biomarkers, such as ROR1, by different methods (e.g., IHC versus next-generation sequencing [NGS]) | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adults 18 years of age or older with histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumor malignancy who are willing to have archival tumor tissue analyzed for biomarker(s).
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| Name | Affiliation | Role |
|---|---|---|
| Jackie Walling, MBChB, PhD | Lyell Immunopharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accellacare | Rocky Mount | North Carolina | 27804 | United States |
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An Archival tumor tissue sample collected within 3 years prior to enrollment. The sample must consist, at minimum, of 5 freshly cut, unstained 4-5 μM sections cut from a formalin-fixed paraffin-embedded (FFPE) tissue block. The sample must contain sufficient tumor tissue to allow for the evaluation of biomarker expression
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D012008 | Recurrence |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D016889 | Endometrial Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009385 | Neoplastic Processes |
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