Breast AbnormalityNCT01322750
Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma
An observational study of Breast Abnormality, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
With an estimated > 2 million women with undetected breast cancer in the United States, the need for improved early detection is imperative. Early diagnosis for these women is key to minimizing quality life-years lost to disease and optimizing success of treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Abnormality
- How many people
- 3,125 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jan 2023
- 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: All adults (> 18 years of age) presenting for evaluation at breast center - who subsequently undergo a diagnostic or therapeutic procedure and who do not have a prior history of invasive carcinoma or clinically-apparent metastatic disease, will be eligible for enrollment.
Who may be able to join
- Adults 18 years of age or older
- Mentally competent and willing to provide written informed consent prior to entering the study
- Military healthcare beneficiary
- Undergoing a diagnostic or therapeutic procedure (biopsy, lumpectomy, mastectomy) in the breast clinic or operating room.
- Present to the CBCP and willing to be followed at the CBCP during the course of treatment and follow-up
Who cannot join
- Prior history of invasive carcinoma
- Presence of clinically-apparent metastatic disease
- Participants with known human immunodeficiency virus (HIV), any history of hepatitis, prion-mediated disease, drug resistant tuberculosis or other infectious disease presenting a significant risk to personnel handling tissue or blood-derived products shall be excluded from participation
- Participants with pre-existing coagulopathies or all other conditions, for whom invasive biopsy or surgery is medically contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Thomas P Baker, MD, 202-782-7743, Thomas.P.Baker@us.army.mil
About this study
With an estimated > 2 million women with undetected breast cancer in the United States, the need for improved early detection is imperative. Early diagnosis for these women is key to minimizing quality life-years lost to disease and optimizing success of treatment. Evidence now exists supporting the finding that systemic spread is an early event in the natural history of breast cancer, manifested as a release of single cancer cells from the incident, clinically undetectable tumor, which circulate through the bloodstream and deposit within remote tissues. Reliable and accurate detection of these circulating tumor cells (CTCs) is now possible with a simple peripheral venous blood draw. This study hypothesizes that women with CTCs and no other signs of malignancy have clinically undetectable disease.
This study will attempt to validate this technology as a breast cancer screening test and acquire data to determine the clinical validity and utility of this proposed screening methodology on a relatively young, ethnically diverse population who are eligible military health care beneficiaries. Furthermore, this study will attempt to bank identified CTCs in order to perform additional molecular analyses in the future. The specific aims are to develop a simple, reliable, cost-effective, and clinically relevant breast cancer screening test in order to identify subclinical disease early in its natural history in subjects at risk of progression to clinically apparent disease over the ensuing decade. The ultimate goal is to decrease the treatment-related morbidity and cause-specific mortality of breast cancer. An experienced team devoted to the care of patients with breast disease has been assembled to achieve this goal.
- Conditions
- Breast Abnormality
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 |
|---|---|---|
| With CTCs | Those individuals whom are identified with CTCs | |
| Without CTCs | Those individuals whom present and did not have CTCs |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2013 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AbnormalityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Bureau of Navy Medicine (BUMED)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322750
- Sponsor's protocol ID
- 354344
- Status last verified
- Mar 2011
- First submitted
- 24 Mar 2011
- Last updated
- 25 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma
- ClinicalTrials.gov ID
- NCT01322750
- Acronym / sponsor ID
- 354344
- Conditions
- Breast Abnormality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,125 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- Bureau of Navy Medicine (BUMED)
- Study start
- Dec 2010
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 25 Mar 2011 (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.
With an estimated > 2 million women with undetected breast cancer in the United States, the need for improved early detection is imperative. Early diagnosis for these women is key to minimizing quality life-years lost to disease and optimizing success of treatment. Evidence now exists supporting the finding that systemic spread is an early event in the natural history of breast cancer, manifested as a release of single cancer cells from the incident, clinically undetectable tumor, which circulate through the bloodstream and deposit within remote tissues. Reliable and accurate detection of these circulating tumor cells (CTCs) is now possible with a simple peripheral venous blood draw. This study hypothesizes that women with CTCs and no other signs of malignancy have clinically undetectable disease.
This study will attempt to validate this technology as a breast cancer screening test and acquire data to determine the clinical validity and utility of this proposed screening methodology on a relatively young, ethnically diverse population who are eligible military health care beneficiaries. Furthermore, this study will attempt to bank identified CTCs in order to perform additional molecular analyses in the future. The specific aims are to develop a simple, reliable, cost-effective, and clinically relevant breast cancer screening test in order to identify subclinical disease early in its natural history in subjects at risk of progression to clinically apparent disease over the ensuing decade. The ultimate goal is to decrease the treatment-related morbidity and cause-specific mortality of breast cancer. An experienced team devoted to the care of patients with breast disease has been assembled to achieve this goal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With CTCs | – | –Those individuals whom are identified with CTCs |
| Without CTCs | – | –Those individuals whom present and did not have CTCs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults (> 18 years of age) presenting for evaluation at breast center - who subsequently undergo a diagnostic or therapeutic procedure and who do not have a prior history of invasive carcinoma or clinically-apparent metastatic disease, will be eligible for enrollment.
Key inclusion criteria (5 listed)
- Adults 18 years of age or older
- Mentally competent and willing to provide written informed consent prior to entering the study
- Military healthcare beneficiary
- Undergoing a diagnostic or therapeutic procedure (biopsy, lumpectomy, mastectomy) in the breast clinic or operating room.
- Present to the CBCP and willing to be followed at the CBCP during the course of treatment and follow-up
Key exclusion criteria (4 listed)
- Prior history of invasive carcinoma
- Presence of clinically-apparent metastatic disease
- Participants with known human immunodeficiency virus (HIV), any history of hepatitis, prion-mediated disease, drug resistant tuberculosis or other infectious disease presenting a significant risk to personnel handling tissue or blood-derived products shall be excluded from participation
- Participants with pre-existing coagulopathies or all other conditions, for whom invasive biopsy or surgery is medically contraindicated
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
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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.
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 Abnormality, run by Walter Reed Army Medical Center 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 4 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: status not confirmed, as of the sponsor's last update on 25 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas A Summers, MD (202 782 7743, thomas.summersjr@us.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 25 Mar 2011.