CarcinogenesisNCT02638402
Expression of Altered Glycosyltransferases, Mucins, and RTKs in Human Ovarian and Endometrial Cancers
An observational study of Carcinogenesis and Ovarian Cancer, run by National Taiwan University Hospital.
Trial summary
To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in various stages and/or histologic subtypes of human… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Carcinogenesis, Ovarian Cancer, Endometrial Cancer
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Aug 2017
- 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: Ovarian and endometrial cancer patients receiving operation in National Taiwan University Hospital
Who may be able to join
- Ovarian and endometrial cancer patients receiving operation in National Taiwan University Hospital
Who cannot join
- Recurrence or non-operable patients
Trial locations and contacts
No sites are listed yet.
About this study
To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays.
Read the detailed description
Glycosylation is a widely utilized chemical modification of proteins and lipids in mammalian cells during which saccharide units are covalently attached to the target structures and then sequentially elongated and branched - reactions facilitated by a large number of various glycosyltransferases. Alterations in this process have been associated with malignant transformation. To clarify the critical role of glycosyltransferases, altered Mucins (MUC), and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases (including β-1,4-Galactosyltransferase 1 (B4GALT1), β-1,4-Galactosyltransferase 3 (B4GALT3), β-1,4-N-Acetyl-Galactosaminyl Transferase 3 (B4GALNT3), Polypeptide N-Acetylgalactosaminyltransferase 2 (GALNT2), Polypeptide N-Acetylgalactosaminyltransferase 6 (GALNT6), β1,4-N-acetylglucosaminyltransferase III (GlcNAcT-III), β1,4-N-acetylglucosaminyltransferase V (GlcNAcT-V), and Glycoprotein-N-Acetylgalactosamine 3-Beta-Galactosyltransferase 1 (C1GALT1), Mucins (including MUC1, MUC3, MUC15, and MUC20) and receptor tyrosin kinases (RTKs) family (including epidermal growth factor receptor (EGFR), Src, VEGFR, and c-Met) in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays, and compare them with clinicopathologic factors including outcome of the patients.
- Conditions
- Carcinogenesis, Ovarian Cancer, Endometrial Cancer
- Keywords
- glycosylation, mucin, receptor tyrosin kinases, ovarian cancer, endometrial cancer
- Medical subject headings
- Carcinogenesis, Ovarian Neoplasms, Endometrial Neoplasms, Medullary cystic kidney disease 1
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 |
|---|---|---|
| Stage I, II, III, IV ovarian cancer | Stage I, II, III, IV ovarian cancer receive treatment in National Taiwan University Hospital | |
| Stage I, II, III, IV endometrial cancer | Stage I, II, III, IV endometrial cancer receive treatment in National Taiwan University Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the Immunohistochemistry (IHC) expression
Measured: 5 years after patient received surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinogenesisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Hau Chen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638402
- Sponsor's protocol ID
- 201405068RINA
- Status last verified
- May 2016
- First submitted
- 20 Dec 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Altered Glycosyltransferases, Mucins, and RTKs in Human Ovarian and Endometrial Cancers
- ClinicalTrials.gov ID
- NCT02638402
- Acronym / sponsor ID
- 201405068RINA
- Conditions
- Carcinogenesis, Ovarian Cancer, Endometrial Cancer
- Keywords
- glycosylation, mucin, receptor tyrosin kinases, ovarian cancer, endometrial cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 23 Dec 2015 (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.
To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays.
Detailed description
Glycosylation is a widely utilized chemical modification of proteins and lipids in mammalian cells during which saccharide units are covalently attached to the target structures and then sequentially elongated and branched - reactions facilitated by a large number of various glycosyltransferases. Alterations in this process have been associated with malignant transformation. To clarify the critical role of glycosyltransferases, altered Mucins (MUC), and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases (including β-1,4-Galactosyltransferase 1 (B4GALT1), β-1,4-Galactosyltransferase 3 (B4GALT3), β-1,4-N-Acetyl-Galactosaminyl Transferase 3 (B4GALNT3), Polypeptide N-Acetylgalactosaminyltransferase 2 (GALNT2), Polypeptide N-Acetylgalactosaminyltransferase 6 (GALNT6), β1,4-N-acetylglucosaminyltransferase III (GlcNAcT-III), β1,4-N-acetylglucosaminyltransferase V (GlcNAcT-V), and Glycoprotein-N-Acetylgalactosamine 3-Beta-Galactosyltransferase 1 (C1GALT1), Mucins (including MUC1, MUC3, MUC15, and MUC20) and receptor tyrosin kinases (RTKs) family (including epidermal growth factor receptor (EGFR), Src, VEGFR, and c-Met) in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays, and compare them with clinicopathologic factors including outcome of the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage I, II, III, IV ovarian cancer | – | –Stage I, II, III, IV ovarian cancer receive treatment in National Taiwan University Hospital |
| Stage I, II, III, IV endometrial cancer | – | –Stage I, II, III, IV endometrial cancer receive treatment in National Taiwan University Hospital |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ovarian and endometrial cancer patients receiving operation in National Taiwan University Hospital
Key inclusion criteria (1 listed)
- Ovarian and endometrial cancer patients receiving operation in National Taiwan University Hospital
Key exclusion criteria (1 listed)
- Recurrence or non-operable patients
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
Measure the Immunohistochemistry (IHC) expression
Time frame: 5 years after patient received surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: No
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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.
Chi-Hau Chen, MD, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinogenesis and Ovarian Cancer, run by National Taiwan University Hospital.
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 13 May 2016. 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 Chi-Hau Chen, MD, PhD (+886-972651980, chihau@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the Immunohistochemistry (IHC) expression (time frame: 5 years after patient received surgery). It is what the study was designed to measure, not a finding.
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 13 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.