Malignant Neoplasm of Breast.NCT01943032
Discordant Hormonal Status of Breast Cancer.
An observational study of Malignant Neoplasm of Breast., run by National Cancer Institute, Thailand at 1 site in Thailand.
Trial summary
The purpose of this study is to determine discordant hormonal status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Malignant Neoplasm of Breast.
- How many people
- 105 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2011to Apr 2012
- How long will I take part?
- 1 Year
- 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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast Cancer Patients Stage I,II and III.
Who may be able to join
- Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.
Who cannot join
- Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
National Cancer Institute, Thailand.
Ratchathewi, Bangkok, 10400
About this study
Official title: Discordant Hormonal Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.
The purpose of this study is to determine discordant hormonal status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.
Read the detailed description
Hormonal status between primary breast tumor and axillary lymph node were analyzed.
- Conditions
- Malignant Neoplasm of Breast.
- 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 |
|---|---|---|
| Primary Breast Tumor | Immunohistochemical staining of paraffin embedded tissue blocks of primary breast tumor for estrogen and progesterone receptors was performed. | |
| Axillary Lymph Nodes. | Immunohistochemical staining of paraffin embedded tissue blocks of axillary lymph nodes for estrogen and progesterone receptors was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of hormonal status between primary breast tumor and axillary lymph nodes
Association of estrogen and progesterone status between primary breast tumor and axillary lymph nodes was analyzed by using the χ2 test
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startApr 2011
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of Breast.Studies 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
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Thailand
- Sponsor type
- Other government
- Responsible party
- Principal investigator, AKANIST PIYAPANT, MD.,FRCST., National Cancer Institute, Thailand
- Investigators
- AKANIST PIYAPANT, MD.,FRCST., Principal investigator, National Cancer Institute, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943032
- Sponsor's protocol ID
- EC 196/2010
- Status last verified
- Sep 2013
- First submitted
- 10 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
PubMed 15317891Cristofanilli M. The biological information obtainable from circulating tumor cells. Breast. 2009 Oct;18 Suppl 3:S38-40. doi: 10.1016/S0960-9776(09)70270-X.
PubMed 19914540
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discordant Hormonal Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT01943032
- Acronym / sponsor ID
- EC 196/2010
- Conditions
- Malignant Neoplasm of Breast.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National Cancer Institute, ThailandOther government
- Study start
- Apr 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 16 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.
The purpose of this study is to determine discordant hormonal status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.
Detailed description
Hormonal status between primary breast tumor and axillary lymph node were analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Breast Tumor | – | –Immunohistochemical staining of paraffin embedded tissue blocks of primary breast tumor for estrogen and progesterone receptors was performed. |
| Axillary Lymph Nodes. | – | –Immunohistochemical staining of paraffin embedded tissue blocks of axillary lymph nodes for estrogen and progesterone receptors was performed. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer Patients Stage I,II and III.
Key inclusion criteria (1 listed)
- Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.
Key exclusion criteria (1 listed)
- Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.
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
Association of hormonal status between primary breast tumor and axillary lymph nodes
Time frame: Up to 1 year
Association of estrogen and progesterone status between primary breast tumor and axillary lymph nodes was analyzed by using the χ2 test
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 20 Sep 2013.
- Background: PubMed 15317891Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
- Background: PubMed 19914540Cristofanilli M. The biological information obtainable from circulating tumor cells. Breast. 2009 Oct;18 Suppl 3:S38-40. doi: 10.1016/S0960-9776(09)70270-X.
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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.
AKANIST PIYAPANT, MD.,FRCST. principal investigator
National Cancer Institute, Thailand
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 Malignant Neoplasm of Breast., run by National Cancer Institute, Thailand at 1 site in Thailand.
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 20 Sep 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 Thailand. 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?
Association of hormonal status between primary breast tumor and axillary lymph nodes (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01943032, which also lists 2 linked publications.
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 20 Sep 2013.