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

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ClinicalTrials.gov Identifier: NCT02246738
Recruitment Status : Unknown
Verified September 2016 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was:  Recruiting
First Posted : September 23, 2014
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment
Urothelial Carcinoma of the Bladder Other: Blood Collection

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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initial Evaluation of a Telomerase-based Circulating Tumor Cell Assay in Bladder Cancer Cohorts
Study Start Date : August 2014
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 4 Years ]

Biospecimen Retention:   Samples With DNA
Blood Collection


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Urothelial Carcinoma of the Bladder
Criteria

Inclusion Criteria:

  • a.Urothelial carcinoma or mixed urothelial carcinoma arising from the bladder
  • b.Age 18 or older
  • Inclusions by cohort Cohort 1. 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 upfront radical cystectomy. PriorTURBT and intravesical therapies are allowed but should not have been done within one week of CTC measurement. If the patient is found to have no evidence of tumor (pT0) upon evaluation of the cystectomy specimen, the patient will not be dropped. 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 1 and included in Cohort 9 instead.
  • 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.
  • Cohort 7. Patients with a history of muscle invasive bladder cancer (cT1, any N,M0) who have no evidence of disease at least 2 years after the date of radical cystectomy. 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 7 but may be considered for inclusion in Cohort 4.
  • Cohort 8. Patients with a history of muscle invasive bladder cancer (cT1, any N, M0) who have no evidence of disease at least 2 years after the completion of definitive chemo-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 8 but may be considered for inclusion in Cohort 4.
  • Cohort 9. Patients who were initially included in Cohorts 1-6 but were found to have progression at the time of their post-treatment blood draw. Of note, patients may be included in more than one cohort over time so long as inclusion and exclusion criteria are met. In addition, twenty samples from normal controls without any history of malignancy will be used for this study but havealready been collected as part of a separate protocol.

Exclusion Criteria:

  • pure squamous or pure adenocarcinoma bladder cancer histology. This exclusion may be waved at the discretion of the protocol PI. 2. Prior cancer diagnosed within 3 years of enrollment other than a prior bladder, prostate, or skin cancer. This exclusion may be waved at the discretion of the protocol PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246738


Contacts
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Contact: John Christodoules, MD 855-216-0098 PennCancerTrials@emeringmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: John Christodouleas, MD    855-216-0098    PennCancerTrials@emeringmed.com   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: John Christodouleas, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02246738     History of Changes
Other Study ID Numbers: UPCC 07814
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Neoplastic Cells, Circulating
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes