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| ID | Type | Description | Link |
|---|---|---|---|
| CHNMC-07241 | |||
| CDR0000628796 | Registry Identifier | NCI PDQ | |
| NCI-2015-01327 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research trial studies the development of a blood test for detecting anti-insulin-like growth factor II mRNA binding protein 3 (anti-IMP3) antibody and micro ribonucleic acid (microRNA) in patients with renal cell carcinoma (RCC) that has spread to other parts of the body (metastatic) or is limited to the tissue or organ where it began (localized). Anti-IMP3 is a tumor marker that can be detected in many human cancers, including RCC and is likely to be present in the serum (blood) of patients with metastatic or localized RCC. Alterations in microRNA expression has also shown to play a critical role in cancer progression and may be a promising biomarker for patients with RCC. Developing a blood test for anti-IMP3 antibody and microRNA in serum and tissue samples of patients in the laboratory may help doctors find and diagnose RCC earlier, find out how far the disease has spread, and plan effective treatment for RCC.
PRIMARY OBJECTIVE:
I. To develop a blood test by monitoring the titer of IMP3 autoantibody and/or microRNA (miRNA)/small non-coding RNA (snRNA) expression in patients' serum for the early detection of RCC and its recurrence/metastasis.
OUTLINE: Serum samples are collected prior to treatment and analyzed for anti-IMP3 autoantibody titer via enzyme-linked immunosorbent assay (ELISA) and total RNA via sequencing, microarray, and/or quantitative polymerase chain reaction (q-PCR). Previously collected tissue samples are analyzed for IMP3 via immunohistochemistry (IHC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood draw for diagnosis testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic | Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of primary and/or metastatic renal cell carcinoma by IMP3 autoantibody | For the IMP3 autoantibody study, the results of IHC studies of IMP3 on the tissue sections will be used as golden standard to evaluate the sensitivity and specificity of the assay. Statistical significance will be set at P < 0.05 (confidence level of 95%). | Baseline |
| Presence of primary and/or metastatic renal cell carcinoma by miRNA/snRNA signature | For the miRNA/snRNA signature study, the patients' clinical presentation of RCC and its recurrence/metastasis will be used as the golden standard to evaluate the sensitivity and specificity of the assay. Statistical significance will be set at P < 0.05 (confidence level of 95%). | Baseline |
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Inclusion Criteria:
Metastatic RCC Patients' Serum Cohort:
Metastatic RCC Patients' Tissue Cohort:
Exclusion Criteria:
Not applicable
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Patients diagnosed with metastatic or localized RCC
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| Name | Affiliation | Role |
|---|---|---|
| Huiqing Wu, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010-3000 | United States |
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Serum, plasma, and tissue
| protein expression analysis | Genetic | Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples |
|
| diagnostic laboratory biomarker analysis | Diagnostic Test | Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples |
|
| immunoenzyme technique | Other | Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples |
|
| immunohistochemistry staining method | Other | Testing performed on blood draw taken prior to surgery or other treatment and on fresh or frozen primary or metastatic tissue samples |
|
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D007124 | Immunoenzyme Techniques |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D015336 | Molecular Probe Techniques |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
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