Ovarian CancerNCT01823731
A Pilot Test for Newly Developed Synoptic Operative Template for Ovarian Cancer (SOTOC): National Cancer Center - Peritoneal Carcinomatosis Index
An observational study of Ovarian Cancer, run by National Cancer Center, Korea.
Trial summary
objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description of perioperative tumor burden and surgical approaches in the management of ovarian cancer, tubal cancer, and primary peritoneal cancer Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: * ovarian cancer, tubal cancer, primary peritoneal cancer, mesothelioma, pseudomyxoma peritonei * Debulking operation
Who may be able to join
- Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma
- Available preoperative image study (CT and/or MRI and/or PET)
- Patients who gave a written informed consent
- Patients must be surgical candidate considering medical and psychological condition
Who cannot join
- Patients who refuse to participate or want to withdraw at anytime.
About this study
objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description of perioperative tumor burden and surgical approaches in the management of ovarian cancer, tubal cancer, and primary peritoneal cancer
Read the detailed description
- Informed consent
- Digital photography \& Checking PCI (tumor size\& location )
- Postoperative surveillance(tumor marker, image and physical examination)
- Developing the best fitting NCC-PCI template to reflect recurrence and survival pattern
- Conditions
- Ovarian Cancer
- Keywords
- PCI,SOTOC, Ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of Clinical Applicability about Synoptic Operative Template for Ovarian Cancer (SOTOC)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sang-Yoon Park, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823731
- Sponsor's protocol ID
- NCCNCS-13-700
- Status last verified
- Jun 2013
- First submitted
- 29 Mar 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Test for Newly Developed Synoptic Operative Template for Ovarian Cancer (SOTOC): National Cancer Center - Peritoneal Carcinomatosis Index
- ClinicalTrials.gov ID
- NCT01823731
- Acronym / sponsor ID
- NCCNCS-13-700
- Conditions
- Ovarian Cancer
- Keywords
- PCI,SOTOC, Ovarian cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Apr 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.
objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description of perioperative tumor burden and surgical approaches in the management of ovarian cancer, tubal cancer, and primary peritoneal cancer
Detailed description
- Informed consent
- Digital photography \& Checking PCI (tumor size\& location )
- Postoperative surveillance(tumor marker, image and physical examination)
- Developing the best fitting NCC-PCI template to reflect recurrence and survival pattern
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * ovarian cancer, tubal cancer, primary peritoneal cancer, mesothelioma, pseudomyxoma peritonei * Debulking operation
Key inclusion criteria (4 listed)
- Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma
- Available preoperative image study (CT and/or MRI and/or PET)
- Patients who gave a written informed consent
- Patients must be surgical candidate considering medical and psychological condition
Key exclusion criteria (1 listed)
- Patients who refuse to participate or want to withdraw at anytime.
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
evaluation of Clinical Applicability about Synoptic Operative Template for Ovarian Cancer (SOTOC)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by National Cancer Center, 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 4 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 5 Jun 2013. 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?
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?
evaluation of Clinical Applicability about Synoptic Operative Template for Ovarian Cancer (SOTOC) (time frame: one year). 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 5 Jun 2013.