Colorectal CarcinomaNCT06638957
Impact of the COVID-19 Pandemic on Oncologic Outcomes in Colorectal Cancer
An observational study of Colorectal Carcinoma and COVID 19, run by In Ja Park at 1 site in South Korea.
Trial summary
The goal of this observational study is to assess the impact of the COVID-19 pandemic on colorectal cancer (CRC) outcomes, particularly focusing on stage distribution and recurrence-free survival in patients undergoing surgery at eight tertiary care institutions in Korea from 2018 to 2020. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Carcinoma, COVID 19
- How many people
- 14,951 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2018to 20 Sep 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: Between 2018 and 2020, 14951 patients underwent surgery for suspected CRC across the eight institutions.
Who may be able to join
- Patients diagnosed with colorectal cancer who underwent surgery
- in 8 institution including Asan Medical Center, Seoul St. Mary's Hospital, Korea University Anam Hospital, Samsung Medical Center, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital
Who cannot join
- Familial adenomatous polyposis (FAP)
- Hereditary non-polyposis colon cancer (HNPCC)
- Cancer associated with inflammatory bowel disease (IBD)
- Colorectal cancer not proven on biopsy, and pathologies other than adenocarcinoma.
- Emergency operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Coronavirus Disease 2019 Pandemic on Oncologic Outcomes in Colorectal Cancer
The goal of this observational study is to assess the impact of the COVID-19 pandemic on colorectal cancer (CRC) outcomes, particularly focusing on stage distribution and recurrence-free survival in patients undergoing surgery at eight tertiary care institutions in Korea from 2018 to 2020.
Main Question Does the COVID-19 pandemic lead to more advanced stages of colorectal cancer at diagnosis and higher complication rates during surgery? Is there a significant difference in recurrence-free survival between CRC patients treated before and during the pandemic?
Read more
This study found that more patients presented with advanced-stage CRC during the COVID-19 pandemic, with significantly higher rates of tumor-related complications (perforations, abscesses, and preoperative obstructions), as well as an increase in open surgeries and combined resections.
No significant difference in recurrence-free survival was observed between the pre-COVID-19 and COVID-19 periods, although postoperative complication rates were higher, especially among rectal cancer patients and those receiving preoperative chemoradiotherapy.
Read the detailed description
This observational, population-based, cohort study was conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. It was approved by the regional ethics committee in the Republic of Korea and institutional review boards of the eight participating institutions. Due to the anonymity of the data, the requirement for informed consent was waived.
The study timeline was determined by the phased social distancing measures implemented in the Republic of Korea in response to the COVID-19 pandemic. The study focused on patients with CRC who underwent surgical treatment from 2018 to 2020. The pre-COVID-19 period extended from 2018 to February 2020, and the COVID-19 period began in March 2020 with the identification of the first COVID-19 case in the Republic of Korea and subsequent government measures to prevent the spread of the disease.
Eight institutions across the Republic of Korea participated in the study, including Asan Medical Center, Seoul St. Mary's Hospital, Korea University Anam Hospital, Samsung Medical Center, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. These institutions are tertiary medical centers, varying in location and size.
- Conditions
- Colorectal Carcinoma, COVID 19
- Keywords
- colorectal, covid, oncologic outcome
- Medical subject headings
- Colorectal Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with colorectal cancer who underwent surgical treatment from 2018 to 2020 | The pre-COVID-19 period extended from 2018 to February 2020 | |
| patients with colorectal cancer who underwent surgical treatment from 2020 | the COVID-19 period began in March 2020 to December 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
stage distribution in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.
We aimed to document the pathological stage for each patient based on the biopsy results after surgery and analyze how the stage distribution differed between the pre-COVID and COVID groups.
Measured: At the time the biopsy results were available for patients who underwent surgery between 2018 and 2020 (7 days after surgery).
Secondary outcomes (1)
2-year recurrence free survival (RFS) and surgical complication rate in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.
Measured: Outcome measures will be assessed at 2 years post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies 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
- Retrospective
- Enrolment
- 14,951 participants (actual)
Sponsor and investigators
- Lead sponsor
- In Ja Park
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Chilgok Hospital, Gangnam Severance Hospital, Chonnam National University Hospital, Korea University Anam Hospital, Pusan National University Yangsan Hospital, Samsung Medical Center, Seoul Saint Mary's Hospital
- Responsible party
- Sponsor-investigator, In Ja Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638957
- Sponsor's protocol ID
- COVID
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Coronavirus Disease 2019 Pandemic on Oncologic Outcomes in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06638957
- Acronym / sponsor ID
- COVID
- Conditions
- Colorectal Carcinoma, COVID 19
- Keywords
- colorectal, covid, oncologic outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,951 participants (actual)
- Lead sponsor
- In Ja ParkUniversity, hospital or other
- Collaborators
- Kyungpook National University Chilgok Hospital, Gangnam Severance Hospital, Chonnam National University Hospital, Korea University Anam Hospital, Pusan National University Yangsan Hospital, Samsung Medical Center, Seoul Saint Mary's Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 15 Oct 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.
The goal of this observational study is to assess the impact of the COVID-19 pandemic on colorectal cancer (CRC) outcomes, particularly focusing on stage distribution and recurrence-free survival in patients undergoing surgery at eight tertiary care institutions in Korea from 2018 to 2020.
Main Question Does the COVID-19 pandemic lead to more advanced stages of colorectal cancer at diagnosis and higher complication rates during surgery? Is there a significant difference in recurrence-free survival between CRC patients treated before and during the pandemic?
This study found that more patients presented with advanced-stage CRC during the COVID-19 pandemic, with significantly higher rates of tumor-related complications (perforations, abscesses, and preoperative obstructions), as well as an increase in open surgeries and combined resections.
No significant difference in recurrence-free survival was observed between the pre-COVID-19 and COVID-19 periods, although postoperative complication rates were higher, especially among rectal cancer patients and those receiving preoperative chemoradiotherapy.
Detailed description
This observational, population-based, cohort study was conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology guidelines. It was approved by the regional ethics committee in the Republic of Korea and institutional review boards of the eight participating institutions. Due to the anonymity of the data, the requirement for informed consent was waived.
The study timeline was determined by the phased social distancing measures implemented in the Republic of Korea in response to the COVID-19 pandemic. The study focused on patients with CRC who underwent surgical treatment from 2018 to 2020. The pre-COVID-19 period extended from 2018 to February 2020, and the COVID-19 period began in March 2020 with the identification of the first COVID-19 case in the Republic of Korea and subsequent government measures to prevent the spread of the disease.
Eight institutions across the Republic of Korea participated in the study, including Asan Medical Center, Seoul St. Mary's Hospital, Korea University Anam Hospital, Samsung Medical Center, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. These institutions are tertiary medical centers, varying in location and size.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with colorectal cancer who underwent surgical treatment from 2018 to 2020 | – | –The pre-COVID-19 period extended from 2018 to February 2020 |
| patients with colorectal cancer who underwent surgical treatment from 2020 | – | –the COVID-19 period began in March 2020 to December 2020 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between 2018 and 2020, 14951 patients underwent surgery for suspected CRC across the eight institutions.
Key inclusion criteria (2 listed)
- Patients diagnosed with colorectal cancer who underwent surgery
- in 8 institution including Asan Medical Center, Seoul St. Mary's Hospital, Korea University Anam Hospital, Samsung Medical Center, Pusan National University Yangsan Hospital, Gangnam Severance Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital
Key exclusion criteria (5 listed)
- Familial adenomatous polyposis (FAP)
- Hereditary non-polyposis colon cancer (HNPCC)
- Cancer associated with inflammatory bowel disease (IBD)
- Colorectal cancer not proven on biopsy, and pathologies other than adenocarcinoma.
- Emergency operation
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
stage distribution in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.
Time frame: At the time the biopsy results were available for patients who underwent surgery between 2018 and 2020 (7 days after surgery).
We aimed to document the pathological stage for each patient based on the biopsy results after surgery and analyze how the stage distribution differed between the pre-COVID and COVID groups.
1 secondary outcome
2-year recurrence free survival (RFS) and surgical complication rate in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period.
Time frame: Outcome measures will be assessed at 2 years post-surgery.
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 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Colorectal Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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 Colorectal Carcinoma and COVID 19, run by In Ja Park 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 5 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 15 Oct 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?
stage distribution in patients who underwent CRC surgery during the pre-COVID-19 period, compared with those who underwent the surgery during the COVID-19 period. (time frame: At the time the biopsy results were available for patients who underwent surgery between 2018 and 2020 (7 days after surgery).). 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 15 Oct 2024.