Metastatic Breast CancerNCT02111031
Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients
An observational study of Metastatic Breast Cancer and Breast Cancer, run by Janssen Diagnostics, LLC at 2 sites in United States.
Trial summary
The objective of the registry study is to demonstrate the clinical utility of the CELLSEARCH® CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in the United States. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Breast Cancer
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to May 2017
- How long will I take part?
- 9 Months
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: "Cases" of CTC-tested mBC patients being cared for by physicians who routinely (i.e., test at least once every quarter) incorporate CTC testing in their management of mBC patients.
Who may be able to join
- Patient has documented (histologically/pathologically confirmed) mBC diagnosis
- Patient is at least 65 years of age at time of mBC diagnosis
- Patient is male or female
- Patient is being actively treated at the cancer center by a physician who uses or plans to use CTC testing on his mBC patients at lease every quarter.
Who cannot join
- Patients breast cancer is secondary not primary
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients
The objective of the registry study is to demonstrate the clinical utility of the CELLSEARCH® CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in the United States. The objective of the present registry is to demonstrate the impact on patient management of the CELLSEARCH® CTC Test among the Medicare-eligible mBC patients. Hereto the hypothesis that the availability of CTC information provides clinicians important, timely information and impacts treatment decisions, will be tested.
This study is IDE-exempt since CELLSEARCH® CTC Test is a legally marketed device in the US, and is being used in accordance with its labeling.
- Conditions
- Metastatic Breast Cancer, Breast Cancer
- Keywords
- CELLSEARCH, CTC, metastatic breast cancer, Registry, mBC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with documented (histologically/pathologically confirmed) mBC diagnosis, at lease 65 years of age at documented mBC diagnosis, and actively treated by a physician at a participating cancer center who routinely (i.e., test at lease every quarter) use CTC testing (excluding patients who sought consults or second opinions). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results).
Measured: 15 months
The percentage of treatment decisions for which CTC results are indicated to add value to treatment decision making, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
The percentage of treatment decisions for which CTC results are indicated to add value to treatment decision making, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
Measured: 15 Months
Secondary outcomes (2)
The relative value of CTC testing in treatment decisions as compared to other parameters, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
The relative value of CTC testing in treatment decisions as compared to other parameters, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
Measured: 15 months
Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.
Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJan 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: The company decided not to start the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Janssen Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Alberto Montero, MD, Principal investigator, Cleveland Clinic Main Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111031
- Sponsor's protocol ID
- JDX-2014-001
- Status last verified
- Jun 2015
- First submitted
- 8 Apr 2014
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02111031
- Acronym / sponsor ID
- JDX-2014-001
- Conditions
- Metastatic Breast Cancer, Breast Cancer
- Keywords
- CELLSEARCH, CTC, metastatic breast cancer, Registry, mBC
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The company decided not to start the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Diagnostics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- Jan 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 10 Apr 2014 (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.
The objective of the registry study is to demonstrate the clinical utility of the CELLSEARCH® CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in the United States. The objective of the present registry is to demonstrate the impact on patient management of the CELLSEARCH® CTC Test among the Medicare-eligible mBC patients. Hereto the hypothesis that the availability of CTC information provides clinicians important, timely information and impacts treatment decisions, will be tested.
This study is IDE-exempt since CELLSEARCH® CTC Test is a legally marketed device in the US, and is being used in accordance with its labeling.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients with documented (histologically/pathologically confirmed) mBC diagnosis, at lease 65 years of age at documented mBC diagnosis, and actively treated by a physician at a participating cancer center who routinely (i.e., test at lease every quarter) use CTC testing (excluding patients who sought consults or second opinions). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- "Cases" of CTC-tested mBC patients being cared for by physicians who routinely (i.e., test at least once every quarter) incorporate CTC testing in their management of mBC patients.
Key inclusion criteria (4 listed)
- Patient has documented (histologically/pathologically confirmed) mBC diagnosis
- Patient is at least 65 years of age at time of mBC diagnosis
- Patient is male or female
- Patient is being actively treated at the cancer center by a physician who uses or plans to use CTC testing on his mBC patients at lease every quarter.
Key exclusion criteria (1 listed)
- Patients breast cancer is secondary not primary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
Time frame: 15 months
Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results).
The percentage of treatment decisions for which CTC results are indicated to add value to treatment decision making, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
Time frame: 15 Months
The percentage of treatment decisions for which CTC results are indicated to add value to treatment decision making, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
2 secondary outcomes
The relative value of CTC testing in treatment decisions as compared to other parameters, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
Time frame: 15 months
Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.
Time frame: 60 months
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 19 Jun 2015.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Alberto Montero, MD principal investigator
Cleveland Clinic Main Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer and Breast Cancer, run by Janssen Diagnostics, LLC at 2 sites in United States.
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 1 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 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results) (time frame: 15 months). The study lists 2 primary outcomes in all. 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 19 Jun 2015.