Initial Evaluation of a Telomerase-based Circulating Tumor Cell Assay in Bladder Cancer Cohorts

NCT02246738 | Completed DMC

• 1 other identifier: UPCC 07814
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Purposes are to determine whether various cohorts of bladder cancer patients have detectable tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see if tCTC's provide novel information.Study population are various cohorts of patients diangosed with urothelial carcinoma of the bladder.Procedures include a venous blood draw, up to two times, over a 6 month period for collection of tCTC's. Up to 15 mL's of blood will be collected at each blood draw.

Conditions

Urothelial Carcinoma of the Bladder

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  4 Years

Study Arms (9)

Cohort1

Other: Blood Collection

Cohort 2

Other: Blood Collection

Cohort 3

Other: Blood Collection

Cohort 4

Other: Blood Collection

Cohort 5

Other: Blood Collection

Cohort 6

Other: Blood Collection

Cohort 7

Other: Blood Collection

Cohort 8

Other: Blood Collection

Cohort 9

Other: Blood Collection

Interventions

Blood Collection OTHER

Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8; Cohort 9; Cohort1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Urothelial Carcinoma of the Bladder

You may qualify if:

• a.Urothelial carcinoma or mixed urothelial carcinoma arising from the bladder
• b.Age 18 or older
• Cohort 2. Patients with localized muscle-invasive disease (cT1, cN0, M0) at the time of initial diagnosis prior to definitivechemo-radiation. Prior TURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have evidence of progression by anyclinical evaluation performed within 2 months of the post-treatment sample, the patient will be droppedfrom Cohort 2 and included in Cohort 9 instead.
• Cohort 3. Patients with localized muscle-invasive disease (cT1, cN0, M0) at the time of initial diagnosis or who have progressed from superficial disease (cT2) who have not had any systemic chemotherapy and who will be treated with neoadjuvant chemotherapy. Prior TURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 3 and included in Cohort 9 instead.
• Cohort 4. Patients with metastatic disease (anyT, anyN, M1) at initial presentation or recurrent after definitive treatment prior to any salvage systemic chemotherapy. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 4 and included in Cohort 9 instead.
• Cohort 5. Patients with newly diagnosed non-muscle-invasive bladder cancer (T2) prior to any intravesical therapy. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped.
• Cohort 6. Patients with muscle-invasive bladder cancer after radical cystectomy with or without peri-operative systemic chemotherapy (pT2, anyN, M0) who will be treated with adjuvant radiation. If the patient is found to have evidence of progression by any clinical evaluation performed within 2 months of the post-treatment sample, the patient will be dropped from Cohort 6 and includedin Cohort 9 instead.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Collection

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John Christodouleas, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 23, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

US (1)