Anti-IMP3 Autoantibody and MicroRNA Signature Blood Tests in Finding Metastasis in Patients With Localized or Metastatic Kidney Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Kidney Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/10/2017 |
| Start Date: | July 2008 |
| End Date: | November 15, 2017 |
Development of a Blood Test of Anti-IMP3 Autoantibody and Serum MicroRNA Signature for the Detection of Renal Cell Carcinoma With Metastasis and Metastatic Potential
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.
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).
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).
Inclusion Criteria:
Metastatic RCC Patients' Serum Cohort:
- a. Serum samples from patients with metastatic RCC prior to surgical removal of the
metastatic and/or primary lesions
- b. Serum samples from patients with localized RCC prior to surgical removal of the
lesions
- c. Discarded donors' and patients' discarded/leftover plasma/serum samples from blood
bank and other Department of Pathology laboratories
- d. Serum samples from patients with metastatic RCC who had nephrectomies or/and
RCC-related biopsies in the referring hospitals
Metastatic RCC Patients' Tissue Cohort:
- Formalin-fixed paraffin-embedded (FFPE) and/or frozen primary and/or metastatic RCC
tissue samples from the corresponding patients serum who are included in inclusion
criteria (a-b)
- FFPE and/or frozen benign renal tissue samples which are nearby the tumor and remove
during surgical procedures from the corresponding patients who are included in
inclusion criteria (a-b)
- Discarded/leftover FFPE and frozen renal tissue samples from Department of Anatomic
Pathology and its Tumor Bank
- FFPE primary and/or metastatic RCC tissue samples (unstained slides) from the
corresponding patients who are included in inclusion criteria (d)
Exclusion Criteria:
We found this trial at
1
site
Duarte, California 91010
Principal Investigator: Huiqing Wu, MD
Phone: 800-826-4673
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