Rectal CancerNCT04287400
Prospective Trial for the Evaluation of Radiogenomics in Advanced Rectal Cancer
An observational study of Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectal Cancer
- How many people
- 210 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2019to 1 Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery
Who may be able to join
- Age: 20-80 years
- Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery
Who cannot join
- Patients with distal metastases confirmed at diagnosis
- Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer
- If patients do not agree with this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Dae Kyung Sohn, MD,PHD, +82-31-920-1636, gsgsbal@ncc.re.kr
Dae Kyung Sohn, +82-31-920-1761, gsgsbal@ncc.re.kr
About this study
Official title: Prospective Clinical Trial for the Evaluation of Radiogenomics: Correlation, Treatment Response and Prognosis in Patients With Advanced Rectal Cancer, Who Undergo Preoperative Chemoradiation
In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared.
Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival.
A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.
- Conditions
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
K-RAS Mutation
K-RAS Mutation status
Measured: 4 weeks
Secondary outcomes (1)
Radiomics - MR image findings
Radiologic features
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start5 Mar 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dae Kyung Sohn, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287400
- Sponsor's protocol ID
- 2018-0428-0001
- Status last verified
- Sep 2021
- First submitted
- 26 Nov 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial for the Evaluation of Radiogenomics: Correlation, Treatment Response and Prognosis in Patients With Advanced Rectal Cancer, Who Undergo Preoperative Chemoradiation
- ClinicalTrials.gov ID
- NCT04287400
- Acronym / sponsor ID
- 2018-0428-0001
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Feb 2020 (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.
In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared.
Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival.
A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery
Key inclusion criteria (2 listed)
- Age: 20-80 years
- Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery
Key exclusion criteria (3 listed)
- Patients with distal metastases confirmed at diagnosis
- Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer
- If patients do not agree with this study
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
K-RAS Mutation
Time frame: 4 weeks
K-RAS Mutation status
1 secondary outcome
Radiomics - MR image findings
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
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 Rectal 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 2 inclusion and 3 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 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAE KYUNG SOHN (82319201636, gsgsbal@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-RAS Mutation (time frame: 4 weeks). 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 Sep 2021.