Breast CancerNCT01265225
Prognostic Value of Stem Cell Related Markers
An observational study of Breast Cancer, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
The goal of the investigators study is to identify a prognostic marker that will evaluate the probability of recurrence in patients with stage 0-II breast cancer following surgery to remove the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 100 tumor specimens from women with grade 0-11 ductal breast cancer
Who may be able to join
- Ductal Carcinoma in Situ
- DCIS + Microinvasion stages 1 or 11 without positive lymph nodes
Who cannot join
- tumor specimen with higher than grade II
- BRACA 1 or BRACA 2 mutation
- Neoadjuvant chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Stem Cell Related Markers CD24, CD44, CD326 and EPCR, for Predicting Breast Cancer Recurrence in Tumor Stages 0-II
The goal of the investigators study is to identify a prognostic marker that will evaluate the probability of recurrence in patients with stage 0-II breast cancer following surgery to remove the tumor.
- Conditions
- Breast Cancer
- Keywords
- breast cancer stages 0-II
- 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 posted23 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013 (estimated)
- Study completionApr 2013 (estimated)
Why it stopped: no finance
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 only
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265225
- Sponsor's protocol ID
- 10.CTIL
- Status last verified
- Dec 2013
- First submitted
- 21 Dec 2010
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Stem Cell Related Markers CD24, CD44, CD326 and EPCR, for Predicting Breast Cancer Recurrence in Tumor Stages 0-II
- ClinicalTrials.gov ID
- NCT01265225
- Acronym / sponsor ID
- 10.CTIL
- Conditions
- Breast Cancer
- Keywords
- breast cancer stages 0-II
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no finance
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 23 Dec 2010 (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 goal of the investigators study is to identify a prognostic marker that will evaluate the probability of recurrence in patients with stage 0-II breast cancer following surgery to remove the tumor.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 tumor specimens from women with grade 0-11 ductal breast cancer
Key inclusion criteria (2 listed)
- Ductal Carcinoma in Situ
- DCIS + Microinvasion stages 1 or 11 without positive lymph nodes
Key exclusion criteria (3 listed)
- tumor specimen with higher than grade II
- BRACA 1 or BRACA 2 mutation
- Neoadjuvant chemotherapy
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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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 Breast Cancer, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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 2 inclusion and 3 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 24 Dec 2013. 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 Israel. 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.
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 24 Dec 2013.