Stem CellsNCT00340392
Isolation and Characterization of Mammary Stem Cells
An observational study of Stem Cells, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Cancer stem cells in breast cancer have been identified as a small population of tumor cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be necessary for cancer to develop. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stem Cells
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2006to 23 Mar 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The tissue samples will come from the human cooperative network. They have their own set of criteria. We are requesting tissue samples from individuals that are normal as well as those who have cancer.
Who cannot join
- The tissue samples will come from the human cooperative tissue network and we are asking for normal samples from individuals who don't have any opportunistic diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Cancer stem cells in breast cancer have been identified as a small population of tumor cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be necessary for cancer to develop.
- These cells can be identified by certain surface markers that overlap with markers associated with normal embryonic stem cells.
Read more
Objective: To isolate tumor stem cells using the same methods generally used to isolate human embryonic stem cells.
Eligibility:
- Tissue samples will be obtained from the human cooperative network.
- Samples will include normal tissues from individuals who have no opportunistic diseases and from individuals with cancer.
Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.
Read the detailed description
Cancers are composed of heterogeneous populations of cells with varying degrees of proliferative capacity and ability to reconstitute tumors when transplanted into nude or SCID mice.
Recently, cancer stem cells have been identified as a small population of tumor cells which possess the stem cell properties in that their self-renewal pathway is highly deregulated. This deregulation seems to be the prerequisite for the development of cancer.
- Conditions
- Stem Cells
- Keywords
- Mammary Stem Cells, Breast Cancer, Cancer Stem Cells, Gene Expression Profiling
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start7 Apr 2006
- Study completion23 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem CellsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340392
- Sponsor's protocol ID
- 999906140
- Other IDs
- 06-C-N140
- Status last verified
- 23 Mar 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation and Characterization of Mammary Stem Cells
- ClinicalTrials.gov ID
- NCT00340392
- Acronym / sponsor ID
- 999906140
- Conditions
- Stem Cells
- Keywords
- Mammary Stem Cells, Breast Cancer, Cancer Stem Cells, Gene Expression Profiling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 7 Apr 2006
- Study completion
- 23 Mar 2011
- First posted
- 21 Jun 2006 (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.
Background:
- Cancer stem cells in breast cancer have been identified as a small population of tumor cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be necessary for cancer to develop.
- These cells can be identified by certain surface markers that overlap with markers associated with normal embryonic stem cells.
Objective: To isolate tumor stem cells using the same methods generally used to isolate human embryonic stem cells.
Eligibility:
- Tissue samples will be obtained from the human cooperative network.
- Samples will include normal tissues from individuals who have no opportunistic diseases and from individuals with cancer.
Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.
Detailed description
Cancers are composed of heterogeneous populations of cells with varying degrees of proliferative capacity and ability to reconstitute tumors when transplanted into nude or SCID mice.
Recently, cancer stem cells have been identified as a small population of tumor cells which possess the stem cell properties in that their self-renewal pathway is highly deregulated. This deregulation seems to be the prerequisite for the development of cancer.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The tissue samples will come from the human cooperative network. They have their own set of criteria. We are requesting tissue samples from individuals that are normal as well as those who have cancer.
Key exclusion criteria (1 listed)
- The tissue samples will come from the human cooperative tissue network and we are asking for normal samples from individuals who don't have any opportunistic diseases.
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
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 2 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stem Cells, run by National Cancer Institute (NCI) 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 1 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: finished, as of the sponsor's last update on 2 Jul 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.
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 2 Jul 2017.