NeoplasmSCCCR08-23NCT06703957
The Samsung Medical Center Comprehensive Cancer Center Registry from 2008 to 2023
An observational study of Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a retrospective cohort study using the Samsung Medical Center Cancer Registry, including cancer patients between 2008 and 2022. To monitor trends in patient demographics, treatment patterns, and outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm
- How many people
- 301,055 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2008to 31 May 2024
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cancer patient who visited Samsung Medical Center
Who may be able to join
- Patients diagnosed with cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective cohort study using the Samsung Medical Center Cancer Registry, including cancer patients between 2008 and 2022.
To monitor trends in patient demographics, treatment patterns, and outcomes.
Read the detailed description
All medical, administrative, and patient information is saved in an EMR system. Age at diagnosis (years), sex, body mass index, region of residence, marital status at diagnosis, employment status at diagnosis, diagnostic pathways (detected by screening, incidentally diagnosed cancer, detected by symptoms), and diagnostic method were obtained from the ERM by trained cancer registrars. Cancer types were classified based on the GLOBOCAN cancer dictionary, and the latter was the taxonomy used in "Cancer Incidence in Five Continents", and the International Association of Cancer Registries provided both of them. In this study, the cancer classification with 24 types of cancer was used for description based on the Korean National Cancer Registry annual report.
The summary staging system developed under the Surveillance, Epidemiology, and End Results (SEER) program (i.e., SEER summary staging) [12] was used to categorize the extent of tumor invasion or metastasis. Based on the 7th edition of the American Joint Committee on Cancer Staging Manual, SEER data were markedly enriched with tumor grades, invasion/metastasis status (bone, brain, lung, and liver), site-specific variables, and tumor stages.
For procedures such as genetic testing, surgery, chemotherapy and radiation therapy, clinical trial participation, and supportive care center visits, data were extracted from the DARWIN-C clinical data warehouse of Samsung Medical Center.
Trends of the hospital process included applying clinical pathways, fast track, and multi-disciplinary community were obtained from Enterprise Data Warehouse (EDW). Clinical pathways are tools used to guide evidence-based healthcare. A clinical pathway is a structured multidisciplinary care plan that details the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol, or other inventory of actions. The fast-track treatment system is additional tests for surgery, and decisions about surgery are all done on the first day of the visit for patients diagnosed with cancer who require surgery. Multi-disciplinary community is to bring together a group of healthcare professionals from different fields to determine patients' treatment plans. Survival status and date of death were obtained from the mortality database of the Ministry of the Interior and Safety. Overall survival (OS) was defined as the time from the date of diagnosis to death from any cause.
- Conditions
- Neoplasm
- Keywords
- Cancer, Registry
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to 5 years after cancer diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start1 Jan 2008
- Primary completion31 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 301,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Yong Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703957
- Sponsor's protocol ID
- SMC cancer registry 08-23
- Acronym
- SCCCR08-23
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Samsung Medical Center Comprehensive Cancer Center Registry from 2008 to 2023
- ClinicalTrials.gov ID
- NCT06703957
- Acronym / sponsor ID
- SCCCR08-23 / SMC cancer registry 08-23
- Conditions
- Neoplasm
- Keywords
- Cancer, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301,055 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 25 Nov 2024 (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.
This is a retrospective cohort study using the Samsung Medical Center Cancer Registry, including cancer patients between 2008 and 2022.
To monitor trends in patient demographics, treatment patterns, and outcomes.
Detailed description
All medical, administrative, and patient information is saved in an EMR system. Age at diagnosis (years), sex, body mass index, region of residence, marital status at diagnosis, employment status at diagnosis, diagnostic pathways (detected by screening, incidentally diagnosed cancer, detected by symptoms), and diagnostic method were obtained from the ERM by trained cancer registrars. Cancer types were classified based on the GLOBOCAN cancer dictionary, and the latter was the taxonomy used in "Cancer Incidence in Five Continents", and the International Association of Cancer Registries provided both of them. In this study, the cancer classification with 24 types of cancer was used for description based on the Korean National Cancer Registry annual report.
The summary staging system developed under the Surveillance, Epidemiology, and End Results (SEER) program (i.e., SEER summary staging) [12] was used to categorize the extent of tumor invasion or metastasis. Based on the 7th edition of the American Joint Committee on Cancer Staging Manual, SEER data were markedly enriched with tumor grades, invasion/metastasis status (bone, brain, lung, and liver), site-specific variables, and tumor stages.
For procedures such as genetic testing, surgery, chemotherapy and radiation therapy, clinical trial participation, and supportive care center visits, data were extracted from the DARWIN-C clinical data warehouse of Samsung Medical Center.
Trends of the hospital process included applying clinical pathways, fast track, and multi-disciplinary community were obtained from Enterprise Data Warehouse (EDW). Clinical pathways are tools used to guide evidence-based healthcare. A clinical pathway is a structured multidisciplinary care plan that details the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol, or other inventory of actions. The fast-track treatment system is additional tests for surgery, and decisions about surgery are all done on the first day of the visit for patients diagnosed with cancer who require surgery. Multi-disciplinary community is to bring together a group of healthcare professionals from different fields to determine patients' treatment plans. Survival status and date of death were obtained from the mortality database of the Ministry of the Interior and Safety. Overall survival (OS) was defined as the time from the date of diagnosis to death from any cause.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patient who visited Samsung Medical Center
Key inclusion criteria (1 listed)
- Patients diagnosed with cancer
Key exclusion criteria (0 listed)
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
Overall survival
Time frame: Up to 5 years after cancer diagnosis.
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 25 Nov 2024.
- 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.
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 Neoplasm, 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 0 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 25 Nov 2024. 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?
Overall survival (time frame: Up to 5 years after cancer diagnosis.). 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 25 Nov 2024.