Breast CancerNCT04093609
XIST Gene Deletion in Breast Cancer Therapy
An observational study of Breast Cancer, run by Assiut University.
Trial summary
Very little is known about the role of X-inactive specific transcript RNA in human breast cancer and in regulating different response to therapy . the relation between the breast cancer predisposing gene BRCA1 \& X-inactive specific transcript RNA has been investigated but still controversial. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- XIST gene deletion
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Mar 2022
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed female patients of breast cancer admitted to south egypt cancer institute above age of 20 years at different stages of the disease
Who may be able to join
- Newly diagnosed patients of breast cancer admitted to south egypt cancer institute at different stages of the disease
Who cannot join
- Other malignant diseases. Male breast cancer . Female with other sex linked diseases . Patients received chemotherapy for breast cancer .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection of XIST Gene Deletion by Fluorescence in Situ Hybridization in Patients With Breast Cancer and Its Relation With Different Response to Therapies
Very little is known about the role of X-inactive specific transcript RNA in human breast cancer and in regulating different response to therapy .
the relation between the breast cancer predisposing gene BRCA1 \& X-inactive specific transcript RNA has been investigated but still controversial.
Loss of X chromosome inactivation (XCI) is observed in breast cancer . Other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour.
Read the detailed description
breast cancer is an important cause of morbidity and mortality in women .Genetics of female contributes to her risk of having breast cancer . this disease is still discovered in their late stages due to the negligence of females inspite of self inspection and clinical examination of the breast .the identification of markers that could predict the tumor behavior is important in breast cancer management , staging, evaluation of therapeutic response and development of new therapeutic modalities .XIST (X-inactive specific transcript) RNA is a long non -coding RNA which plays an important role in inactivation of x_ chromosome which act as an example for long non _ coding RNA mediated gene regulation .Very little is known about the role of XIST in human breast cancer and in regulating different response on therapy . the relation between the breast cancer predisposing gene BRCA1 \& XIST has been investigated but still controversial .Loss of X chromosome inactivation (XCI) is observed in breast . some studies provide evedience that BRCA1 Is involved in XIST regulation on the active X chromosome but not its localization .other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour .
- Conditions
- Breast Cancer
- Being tested
- XIST gene deletion
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIST gene deletionGenetic
detection of XIST gene deletion by fluorescence in situ hybridization
| Study group | Role | What they receive |
|---|---|---|
| cases | Not described Receives: Genetic: XIST gene deletion | |
| control | Not described Receives: Genetic: XIST gene deletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of X inactive specific transcript RNA deletion in patients with breast cancer
detection of X inactive specific transcript RNA deletion by fluorescence in situ hybridization in patients with breast cancer and its relation with different response to therapies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CN Fayez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093609
- Sponsor's protocol ID
- Xist
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lima ZS, Ghadamzadeh M, Arashloo FT, Amjad G, Ebadi MR, Younesi L. Recent advances of therapeutic targets based on the molecular signature in breast cancer: genetic mutations and implications for current treatment paradigms. J Hematol Oncol. 2019 Apr 11;12(1):38. doi: 10.1186/s13045-019-0725-6.
PubMed 30975222Akram M, Iqbal M, Daniyal M, Khan AU. Awareness and current knowledge of breast cancer. Biol Res. 2017 Oct 2;50(1):33. doi: 10.1186/s40659-017-0140-9.
PubMed 28969709Yue M, Charles Richard JL, Yamada N, Ogawa A, Ogawa Y. Quick fluorescent in situ hybridization protocol for Xist RNA combined with immunofluorescence of histone modification in X-chromosome inactivation. J Vis Exp. 2014 Nov 26;(93):e52053. doi: 10.3791/52053.
PubMed 25489864Giudice A, Barbieri A, Bimonte S, Cascella M, Cuomo A, Crispo A, D'Arena G, Galdiero M, Della Pepa ME, Botti G, Caraglia M, Capunzo M, Arra C, Montella M. Dissecting the prevention of estrogen-dependent breast carcinogenesis through Nrf2-dependent and independent mechanisms. Onco Targets Ther. 2019 Jun 24;12:4937-4953. doi: 10.2147/OTT.S183192. eCollection 2019.
PubMed 31388303Banin Hirata BK, Oda JM, Losi Guembarovski R, Ariza CB, de Oliveira CE, Watanabe MA. Molecular markers for breast cancer: prediction on tumor behavior. Dis Markers. 2014;2014:513158. doi: 10.1155/2014/513158. Epub 2014 Jan 28.
PubMed 24591761
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of XIST Gene Deletion by Fluorescence in Situ Hybridization in Patients With Breast Cancer and Its Relation With Different Response to Therapies
- ClinicalTrials.gov ID
- NCT04093609
- Acronym / sponsor ID
- Xist
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 18 Sep 2019 (actual)
- 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.
Very little is known about the role of X-inactive specific transcript RNA in human breast cancer and in regulating different response to therapy .
the relation between the breast cancer predisposing gene BRCA1 \& X-inactive specific transcript RNA has been investigated but still controversial.
Loss of X chromosome inactivation (XCI) is observed in breast cancer . Other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour.
Detailed description
breast cancer is an important cause of morbidity and mortality in women .Genetics of female contributes to her risk of having breast cancer . this disease is still discovered in their late stages due to the negligence of females inspite of self inspection and clinical examination of the breast .the identification of markers that could predict the tumor behavior is important in breast cancer management , staging, evaluation of therapeutic response and development of new therapeutic modalities .XIST (X-inactive specific transcript) RNA is a long non -coding RNA which plays an important role in inactivation of x_ chromosome which act as an example for long non _ coding RNA mediated gene regulation .Very little is known about the role of XIST in human breast cancer and in regulating different response on therapy . the relation between the breast cancer predisposing gene BRCA1 \& XIST has been investigated but still controversial .Loss of X chromosome inactivation (XCI) is observed in breast . some studies provide evedience that BRCA1 Is involved in XIST regulation on the active X chromosome but not its localization .other studies sheds light on a possible mechanism of breast carcinogenesis mediated by XIST misbehaviour .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Genetic: XIST gene deletion |
| control | – | Genetic: XIST gene deletion |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed female patients of breast cancer admitted to south egypt cancer institute above age of 20 years at different stages of the disease
Key inclusion criteria (1 listed)
- Newly diagnosed patients of breast cancer admitted to south egypt cancer institute at different stages of the disease
Key exclusion criteria (1 listed)
- Other malignant diseases. Male breast cancer . Female with other sex linked diseases . Patients received chemotherapy for breast cancer .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIST gene deletiondetection of XIST gene deletion by fluorescence in situ hybridization | Genetic | cases, control |
Primary outcome
detection of X inactive specific transcript RNA deletion in patients with breast cancer
Time frame: 3 years
detection of X inactive specific transcript RNA deletion by fluorescence in situ hybridization in patients with breast cancer and its relation with different response to therapies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Background: PubMed 30975222Lima ZS, Ghadamzadeh M, Arashloo FT, Amjad G, Ebadi MR, Younesi L. Recent advances of therapeutic targets based on the molecular signature in breast cancer: genetic mutations and implications for current treatment paradigms. J Hematol Oncol. 2019 Apr 11;12(1):38. doi: 10.1186/s13045-019-0725-6.
- Background: PubMed 28969709Akram M, Iqbal M, Daniyal M, Khan AU. Awareness and current knowledge of breast cancer. Biol Res. 2017 Oct 2;50(1):33. doi: 10.1186/s40659-017-0140-9.
- Background: PubMed 25489864Yue M, Charles Richard JL, Yamada N, Ogawa A, Ogawa Y. Quick fluorescent in situ hybridization protocol for Xist RNA combined with immunofluorescence of histone modification in X-chromosome inactivation. J Vis Exp. 2014 Nov 26;(93):e52053. doi: 10.3791/52053.
- Background: PubMed 31388303Giudice A, Barbieri A, Bimonte S, Cascella M, Cuomo A, Crispo A, D'Arena G, Galdiero M, Della Pepa ME, Botti G, Caraglia M, Capunzo M, Arra C, Montella M. Dissecting the prevention of estrogen-dependent breast carcinogenesis through Nrf2-dependent and independent mechanisms. Onco Targets Ther. 2019 Jun 24;12:4937-4953. doi: 10.2147/OTT.S183192. eCollection 2019.
- Background: PubMed 24591761Banin Hirata BK, Oda JM, Losi Guembarovski R, Ariza CB, de Oliveira CE, Watanabe MA. Molecular markers for breast cancer: prediction on tumor behavior. Dis Markers. 2014;2014:513158. doi: 10.1155/2014/513158. Epub 2014 Jan 28.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Eman Mosaad Zaki, PhD (00201065518821, Eman_mosaad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of X inactive specific transcript RNA deletion in patients with breast cancer (time frame: 3 years). 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 NCT04093609, which also lists 5 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 18 Sep 2019.