Breast CancerNCT01943500
Collection of Blood Specimens for Circulating Tumor Cell Analysis
An observational study of Breast Cancer and Prostate Cancer, run by Viatar LLC at 1 site in United States.
Trial summary
Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2013to 26 Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Confirmed patients with stage II-IV breast, prostate, or colorectal cancer, (Or) subjects with no prior history of cancer.
Who may be able to join
- Age > 18 years of age
- Written informed consent obtained
- Confirmed diagnosis of stage 2-4 breast, prostate, or colorectal cancer, (OR) no prior history of cancer
- Stage 2-4 treatment naive, metastatic, secondary, and recurrent cancer patients
- Able to undergo blood collection prior to initiation of chemotherapy treatment, (OR) able to provide blood sample if subject is a non-cancer control subject
Who cannot join
- Patients unable to understand the research protocol and/or provide informed consent.
- Patients with known immunodeficiency, or pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Commonwealth Hematology-Oncology, P.C.
Lawrence, Massachusetts, 01841-2310
About this study
Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs).
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- Keywords
- Breast cancer, Prostate cancer, Colorectal cancer, Circulating tumor cell (CTC)
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Neoplastic Cells, Circulating
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 |
|---|---|---|
| Cancer or no prior history of cancer | Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter.
Blood samples will be collected from study subjects and analyzed for the number of circulating tumor cells (CTCs) within 96 hours of blood collection.
Measured: Analysis will be performed within 96 hours following blood sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study start30 Sep 2013
- Primary completion28 Jan 2014
- Study completion26 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatar LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Commonwealth Hematology-Oncology, P.C.
- Responsible party
- Sponsor
- Investigators
- Pedro M Sanz-Altamira, MD, PhD, Principal investigator, Commonwealth Hematology-Oncology, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943500
- Sponsor's protocol ID
- T30-0001
- Status last verified
- Feb 2017
- First submitted
- 10 Sep 2013
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood Specimens for Circulating Tumor Cell Analysis
- ClinicalTrials.gov ID
- NCT01943500
- Acronym / sponsor ID
- T30-0001
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- Keywords
- Breast cancer, Prostate cancer, Colorectal cancer, Circulating tumor cell (CTC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Viatar LLCIndustry (pharma, biotech, devices)
- Collaborators
- Commonwealth Hematology-Oncology, P.C.
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 28 Jan 2014 (actual)
- Study completion
- 26 Aug 2016 (actual)
- First posted
- 17 Sep 2013 (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.
Objective: To test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (CTCs).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer or no prior history of cancer | – | –Confirmed patients with breast, prostate, or colorectal cancer (OR) subjects with no prior history of cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed patients with stage II-IV breast, prostate, or colorectal cancer, (Or) subjects with no prior history of cancer.
Key inclusion criteria (5 listed)
- Age > 18 years of age
- Written informed consent obtained
- Confirmed diagnosis of stage 2-4 breast, prostate, or colorectal cancer, (OR) no prior history of cancer
- Stage 2-4 treatment naive, metastatic, secondary, and recurrent cancer patients
- Able to undergo blood collection prior to initiation of chemotherapy treatment, (OR) able to provide blood sample if subject is a non-cancer control subject
Key exclusion criteria (2 listed)
- Patients unable to understand the research protocol and/or provide informed consent.
- Patients with known immunodeficiency, or pregnancy.
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
The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter.
Time frame: Analysis will be performed within 96 hours following blood sample collection
Blood samples will be collected from study subjects and analyzed for the number of circulating tumor cells (CTCs) within 96 hours of blood collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Pedro M Sanz-Altamira, MD, PhD principal investigator
Commonwealth Hematology-Oncology, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Viatar LLC at 1 site 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 5 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: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of circulating tumor cells (CTCs) per milliliter of whole blood. Reported unit of measure will be the number of CTCs/milliliter. (time frame: Analysis will be performed within 96 hours following blood sample collection). 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 15 Feb 2017.