Genomic Imprinting Testing for Diagnosis of Bladder Cancer

NCT03563443 | Unknown

• 1 other identifier: CH-urology-bladder marker-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Urine analysis provide a promising non-invasive liquid biopsy for diagnosis of bladder cancer. Molecular biomarkers in urine may serve as important diagnostic and prognostic indicators for bladder cancer. Many alterations of genes and proteins have been identified in the urinary for diagnosis of bladder cancer. However, not all bladder cancer patients have the same alterations due to tumor heterogeneity. Thus, to reach satisfactory sensitivity and specificity a new diagnostic molecular alteration should exists ubiquitously in cancers. Numerous studies indicate that Loss of imprinting (LOI) exists ubiquitously in cancers and precede morphological changes. The investigators will conduct a prospective evaluation of a panel of LOI changes in urine test for detection and surveillance of bladder cancer patients.

Conditions

Bladder Cancer; Urine Marking; Diagnoses Disease

Keywords

Bladder Cancer; Genomic imprinting; Urine biomarker; Diagnosis; Surveillance

Outcome Measures

Primary Outcomes (2)

• Sensitivity of urinalysis by LOI urine analysis

  Number of patients "declared positive" with the LOI urine test among the patients suffered from bladder cancer

  In the middle of the study, an average of 12 months

• Specificity of urinalysis by LOI urine analysis

  Number of patients "declared negative" with the LOI urine test among the patients who are without cancer

  In the middle of the study, an average of 12 months

Secondary Outcomes (4)

• Identification of sensitivity of urinalysis by LOI urine analysis to predict the recurrence of bladder cancer within 1 year after transurethral resection of NMIBC

  Through study completion, an average of 24 months

• Identification of specificity of urinalysis by LOI urine analysis to predict the free of bladder cancer recurrence within 1 year after transurethral resection of NMIBC

  Through study completion, an average of 24 months

• Comparison of the sensitivity of the urine LOI analysis versus urine cytology

  In the middle of the study, an average of 12 months

• Comparison of the specificity of the urine LOI analysis versus urine cytology

  In the middle of the study, an average of 12 months

Study Arms (2)

Bladder cancer patients

Diagnosed bladder cancer patients who are being monitored will be the experimental group to develop the LOI panel, and subsequent cohort will be used to confirm the sensitivity and specificity of this urinary analysis.

Diagnostic Test: Genomic Imprinting Testing

Non-cancer participants

Patients being treated for other diseases but without any tumor or healthy participants will provide a negative control to provide data for developing the LOI diagnostic panel

Diagnostic Test: Genomic Imprinting Testing

Interventions

Genomic Imprinting Testing DIAGNOSTIC_TEST

The changes of LOI The obtained LOI from morning urine and tumor will be tested by LiSen imprinting diagnostic (LSID)

Bladder cancer patients; Non-cancer participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with bladder cancer or participants in control group in Changhai Hospital from December 2017 till the end of this study.

You may qualify if:

• \- 1. Patients diagnosed with of bladder cancer by cystoscopy and biopsy. 2. Participants without any tumor disease and willing to attend the study by providing morning urine.
• \. Moring urine and available tumor tissue obtained by biopsy. 4. Male or female patients aged \>= 18 years. 5. Participants signed informed consent form.

You may not qualify if:

• \- 1. Age under 18 years 2. Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery 3. Comorbidities that will prohibit or make serial urine collection and cystoscopic examination difficult or impossible during follow up.
• \. Prior diagnosis of cancer except bladder cancer

Sponsors & Collaborators

• Changhai Hospital: lead
• LiSen imprinting diagnostic (LSID) Company: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (4)

• Jelinic P, Shaw P. Loss of imprinting and cancer. J Pathol. 2007 Feb;211(3):261-8. doi: 10.1002/path.2116.

  PMID: 17177177 BACKGROUND

• Haig D. Maternal-fetal conflict, genomic imprinting and mammalian vulnerabilities to cancer. Philos Trans R Soc Lond B Biol Sci. 2015 Jul 19;370(1673):20140178. doi: 10.1098/rstb.2014.0178.

  PMID: 26056362 BACKGROUND

• Uribe-Lewis S, Woodfine K, Stojic L, Murrell A. Molecular mechanisms of genomic imprinting and clinical implications for cancer. Expert Rev Mol Med. 2011 Jan 25;13:e2. doi: 10.1017/S1462399410001717.

  PMID: 21262060 BACKGROUND

• Jirtle RL. Genomic imprinting and cancer. Exp Cell Res. 1999 Apr 10;248(1):18-24. doi: 10.1006/excr.1999.4453.

  PMID: 10094809 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Loss of imprinting and Copy number variation (LOI \& CNV) is epigenetic change that the silenced copy of an imprinting gene is activated through demethylation. Numerous studies indicate that LOI exists ubiquitously in cancers and precede morphological changes. In contrast, LOI rarely happens in normal somatic cells. Therefore, the methylation status of imprinting genes can act as a biomarker to detect and analyze the abnormal cast-off cells in urine.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Disease

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chuangliang Xu, M.D., Ph.D

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuxiong Zeng, M.D., Ph.D

CONTACT

+86 18930568759; zengshuxiong@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: June 20, 2018
• Study Start: December 15, 2017
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2019
• Last Updated: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)