MelanomaNCT02828345
Bio-marker Analysis Using Circulating Tumor Cells in Patients With Melanoma
An observational study of Melanoma, run by Abramson Cancer Center at Penn Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Specimen Collection
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Melanoma
Who may be able to join
- 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).
Who cannot join
- Children (less than 18yrs)
- Patients in whom a pre-treatment CTC level cannot be obtained.
About this study
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.
- Conditions
- Melanoma
- Being tested
- Specimen Collection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen CollectionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of changes in CTC level from pre- to post-treatment
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgos Karakousis, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828345
- Sponsor's protocol ID
- UPCC 15613
- Status last verified
- Jan 2020
- First submitted
- 7 Jul 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-marker Analysis Using Circulating Tumor Cells in Patients With Melanoma
- ClinicalTrials.gov ID
- NCT02828345
- Acronym / sponsor ID
- UPCC 15613
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Melanoma
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Children (less than 18yrs)
- Patients in whom a pre-treatment CTC level cannot be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen Collection | Other | – |
Primary outcome
Number of changes in CTC level from pre- to post-treatment
Time frame: two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Related trials for Melanoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingPhase 1
A Study of BI 3810944 in Patients With Advanced Cancer
Solid Tumours, Melanoma
Not yet recruitingPhase 1/2
Combination Immunotherapy Targeting Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgos Karakousis, MD principal investigator
Abramson Cancer Center at Penn Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Abramson Cancer Center at Penn Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of changes in CTC level from pre- to post-treatment (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.