WHYX LesionPhase 4NCT01451034
Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion
A Phase 4 study testing WHYX cancer group in people with WHYX Lesion and Extremely Well Differentiated Intestinal-type Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- WHYX Lesion, Extremely Well Differentiated Intestinal-type Adenocarcinoma
- What is being tested?
- WHYX cancer group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 872 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- From January 2009 to December 2010 enrolled 872 patients with EGC
Who cannot join
- EGC with regional lymph node metastasis in radiologic finding endoscopically suspicious submucosal invasion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)
Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.
- Being tested
- WHYX cancer group
- Keywords
- WHYX lesion, endoscopic resection, complete resection, complete resection rate, endoscopic feature, Average size discrepancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHYX cancer groupProcedure or surgery
WHYX cancer diagnosed by pathologic report
| Study group | Role | What they receive |
|---|---|---|
| WHYX cancer group | Active comparator | WHYX cancer diagnosed by pathologic report Receives: Procedure: WHYX cancer group |
| non-WHYX cancer group | Placebo comparator | all cancer except WHYX cancer diagnosed by pathologic report Receives: Procedure: WHYX cancer group |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection rate
Complete resection was defined to have all of the following features: 1. grossly en bloc resection, 2. Tumor-free lateral and vertical resection margins, 3. No lymphovascular invasion, and 5. A depth of submucosal tumor invasion of less than 500 micrometers.
Measured: 6 months after endoscopical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WHYX LesionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451034
- Sponsor's protocol ID
- 2011-08-022
- Status last verified
- Oct 2011
- First submitted
- 28 Sep 2011
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)
- ClinicalTrials.gov ID
- NCT01451034
- Acronym / sponsor ID
- 2011-08-022
- Keywords
- WHYX lesion, endoscopic resection, complete resection, complete resection rate, endoscopic feature, Average size discrepancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 872 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Oct 2011 (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.
Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHYX cancer group | Active comparator | Procedure: WHYX cancer groupWHYX cancer diagnosed by pathologic report |
| non-WHYX cancer group | Placebo comparator | Procedure: WHYX cancer groupall cancer except WHYX cancer diagnosed by pathologic report |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- From January 2009 to December 2010 enrolled 872 patients with EGC
Key exclusion criteria (1 listed)
- EGC with regional lymph node metastasis in radiologic finding endoscopically suspicious submucosal invasion
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 |
|---|---|---|
| WHYX cancer groupWHYX cancer diagnosed by pathologic report | Procedure or surgery | WHYX cancer group, non-WHYX cancer group |
Primary outcome
complete resection rate
Time frame: 6 months after endoscopical resection
Complete resection was defined to have all of the following features: 1. grossly en bloc resection, 2. Tumor-free lateral and vertical resection margins, 3. No lymphovascular invasion, and 5. A depth of submucosal tumor invasion of less than 500 micrometers.
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 13 Oct 2011.
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?
A Phase 4 study testing WHYX cancer group in people with WHYX Lesion and Extremely Well Differentiated Intestinal-type Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
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 13 Oct 2011. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
complete resection rate (time frame: 6 months after endoscopical resection). 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 Oct 2011.