Ovarian CancerNCT01538498
Development for the Peritoneal Carcinomatosis Index (PCI) in Ovarian Cancer
An observational study of Ovarian Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively Secondary objectives: To establish the relationship and find out clinical significance between PCI, tumor… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to Feb 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: * primary ovarian cancer * non-neoadjuvant * Debulking operation
Who may be able to join
- Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage)
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Develop a Peritoneal Carcinomatosis Index (PCI) in Ovarian
- Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively
- Secondary objectives: To establish the relationship and find out clinical significance between PCI, tumor location and tumor characteristics
Read the detailed description
Patients with primary ovarian cancer
- Informed consent
- Digital photography \& Checking PCI (tumor size, number, and Characteristics)
- Postoperative surveillance(tumor marker, image and physical examination)
- Developing the best fitting PCI model to reflect recurrence-free survival and overall survival
- Selection of items
- Weighting by items and tumor characteristics
- Analysis of prognostic impact of PCI compared to conventional staging system (FIGO stage) for ovarian cancer
- Conditions
- Ovarian Cancer
- Keywords
- PCI, Ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Devleopment for the peritoneal carcinomatosis index (PCI)
Measured: 55 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startApr 2008
- Primary completionNov 2012
- Study completionFeb 2013
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
- 134 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
- NCT01538498
- Sponsor's protocol ID
- NCCCTS-08-309
- Status last verified
- Mar 2013
- First submitted
- 17 Feb 2012
- Last updated
- 28 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Develop a Peritoneal Carcinomatosis Index (PCI) in Ovarian
- ClinicalTrials.gov ID
- NCT01538498
- Acronym / sponsor ID
- NCCCTS-08-309
- Conditions
- Ovarian Cancer
- Keywords
- PCI, Ovarian cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Apr 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Feb 2012 (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.
- Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively
- Secondary objectives: To establish the relationship and find out clinical significance between PCI, tumor location and tumor characteristics
Detailed description
Patients with primary ovarian cancer
- Informed consent
- Digital photography \& Checking PCI (tumor size, number, and Characteristics)
- Postoperative surveillance(tumor marker, image and physical examination)
- Developing the best fitting PCI model to reflect recurrence-free survival and overall survival
- Selection of items
- Weighting by items and tumor characteristics
- Analysis of prognostic impact of PCI compared to conventional staging system (FIGO stage) for ovarian cancer
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * primary ovarian cancer * non-neoadjuvant * Debulking operation
Key inclusion criteria (4 listed)
- Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage)
- 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
Devleopment for the peritoneal carcinomatosis index (PCI)
Time frame: 55 months
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 28 Mar 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.
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 Ovarian Cancer, run by National Cancer Center, Korea 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 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: finished, as of the sponsor's last update on 28 Mar 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 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. 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?
Devleopment for the peritoneal carcinomatosis index (PCI) (time frame: 55 months). 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 28 Mar 2013.