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NCT02828345 Clinical Trial

Bio-marker Analysis Using Circulating Tumor Cells in Patients With Melanoma

Melanoma Clinical Trial

Official title:
Bio-marker Analysis Using Circulating Tumor Cells in Patients With Melanoma

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02828345
Other study ID # UPCC 15613
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 2013
Est. completion date December 2013

Study information
Verified date January 2020
Source Abramson Cancer Center of the University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This research trial studies the levels of a type of biomarker, circulating tumor cells (CTCs), in the blood of patients with stage I-IV melanoma. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Studying samples of blood in the laboratory obtained before and after treatment from patients with melanoma may help doctors learn more about changes that occur in CTC levels and whether they may predict how well patients will respond to therapy.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects must have signed tissue collection consent as described in protocol IRB# 703001,UPCC# 08607, PI: Giorgos Karakousis, MD

- Subjects must be competent to consent for themselves.

- Subjectsmust be adult (18 years or older).

- Subjects must be initiating a new therapy for melanoma (so a pretreatment CTC count can be obtained).

Exclusion Criteria:

- Children (less than 18yrs)

- Patients in whom a pre-treatment CTC level cannot be obtained.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Specimen Collection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Abramson Cancer Center of the University of Pennsylvania

Outcome
Type Measure Description Time frame Safety issue
Primary Number of changes in CTC level from pre- to post-treatment two years
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