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

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


  • Org Study ID: UPCC 07814
  • Secondary ID:
  • NCT ID: NCT02246738
  • NCT Alias:
  • Sponsor: Abramson Cancer Center of the University of Pennsylvania - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: August 2014 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Number of Adverse Events

Primary Outcome 1 - Time Frame: 4 Years

Condition:

  • Urothelial Carcinoma of the Bladder

Eligibility

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: John Christodouleas, MD

Role: Principal Investigator

Affiliation: Abramson Cancer Center of the University of Pennsylvania

Overall Contact

Name: John Christodoules, MD

Phone: 855-216-0098

Email: PennCancerTrials@emeringmed.com

Location

Facility Status Contact
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Recruiting John Christodouleas, MD
855-216-0098
PennCancerTrials@emeringmed.com