Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer
COVID-CRC
Effects of the COVID-19 Pandemic on the Diagnosis, Treatment and Outcomes of Patients Affected by Colorectal Cancer Requiring Surgery: Results From a National Multicentre Cohort Study
1 other identifier
observational
15,000
1 country
45
Brief Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been identified as the cause of the Coronavirus disease 19 (COVID-19), which was initially reported in December 2019 in China and has since rapidly spread worldwide. Since then, the COVID-19 pandemic has caused a detrimental effect of the national health care system, causing a drastic reduction of the screening programs for colorectal cancer and requiring the redistribution of the hospital resources from elective surgery to the care of patients with SARS-Cov\_2 infection requiring admission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2020
CompletedFirst Submitted
Initial submission to the registry
January 13, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFebruary 28, 2022
February 1, 2022
1.4 years
January 13, 2021
February 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Oncologic stage
The stage will be reported at the histological examination according to TNM classification
30 days from the surgery
Palliative surgery
Rate of palliative surgery (defined as any procedure which did not have the aim of radically removing the primary cancer, either planned preoperatively in order to reduce the symptoms, or which became necessary during surgery due to unexpected findings
at time 0 (surgery)
Rate of radical surgery
Surgery is defined radical according to the absence of cancer (R0) at the surgical margins on the histological specimen
30 days from surgery
Secondary Outcomes (8)
Aggressive cancer biology
30 days from the surgery
Rate of clinical T4 cancer at the preoperative staging
At time 0 (surgery)
Liver metastases
At the preoperative staging or at surgery (time 0)
Lung metastases
At the preoperative staging or at surgery (time 0)
Associated symptoms
Before surgery
- +3 more secondary outcomes
Study Arms (2)
Study group
Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2020 and December 2021
Control group
Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2018 and December 2019
Interventions
Surgical procedure for cancer may include: * any radical surgery (right or left hemicolectomy, rectal resection, abdomino-perineal resection, total colectomy, proctocolectomy, and others depending on the tumor site and other tumor characteristics), * surgery for radicalization of cancer polyps previously removed endoscopically * surgery for excision of large polyps which are not removable endoscopically * staging surgery (laparoscopy or laparotomy), in case of advanced-non operable cancer * palliative surgery (defined as any surgery with no curative intent)
Eligibility Criteria
The study will include all adult patients undergoing elective or urgent surgery for proven or suspected colorectal within the study periods
You may qualify if:
- Any patient undergoing radical surgery for histologically confirmed diagnosis of cancer located in the colon, the rectum or the anus; or
- any patient undergoing surgery with oncologic intents, for instance: radicalization of endoscopically removed cancerous polyp; radical surgery to remove large, at-risk polyp which are not removable by endoscopy; or
- any patient undergoing planned or unpredicted palliative surgery for a primary cancer localized in the colon, rectum or anus; or
- any patient undergoing a staging procedure (i.e. staging laparoscopy, surgical exploration), which did not result in any radical surgery due to advanced disease, metastasis, etc.
- and
- age \> 18 years
- elective or urgent surgery
You may not qualify if:
- Colorectal cancer recurring after previous surgery;
- Cancer originating from other organs than the colon, the rectum and the anus;
- Lack of significant histological details (expect when the cancer was not removed)
- lack of 30-day follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Rho Memorial Hospital
Rho, Milan, Italy
Humanitas Research Center
Rozzano, Milan, 40100, Italy
AOU Policlinico di Bari "M. Rubino"
Bari, Italy
Policlinico di Bari
Bari, Italy
Humanitas Gavazzeni Hospital
Bergamo, Italy
Policlinico San Marco
Bergamo, Italy
Maggiore Hospital
Bologna, 40100, Italy
Fondazione Poliambulanza
Brescia, Italy
Spedali Civili
Brescia, Italy
Spedali Civili
Brescia, Italy
Santissima Trinità Hospital
Cagliari, Italy
Vittorio Emanuele III Hospital
Carate Brianza, Italy
San Paolo Hospital
Civitavecchia, Italy
AUSL Romagna Ravenna-Faenza
Faenza, Italy
San Giovanni di Dio Hospital
Florence, Italy
Gardone Val Trompia Hospital
Gardone Val Trompia, Italy
ASST FBF Sacco Hospital
Milan, 20100, Italy
San Raffaele Hospital
Milan, 20100, Italy
ASST Santi Paolo e Carlo Hospital
Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
Mirano Hospital
Mirano, Italy
AORN Cardarelli
Napoli, Italy
Università della Campania Luigi Vanvitelli
Napoli, Italy
Padova University Hospital
Padua, Italy
Veneto Institute of Oncology IOV-IRCCS
Padua, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy
AOU Parma
Parma, Italy
San Matteo Hospital
Pavia, Italy
Pederzoli Hospital
Peschiera del Garda, Italy
Azienda Sanitaria Fiuli Occidentale
Pordenone, Italy
Ceccarini Hospital
Riccione, Italy
Infermi Hospital
Rimini, Italy
Campus Biomedico
Roma, Italy
Fondazione Policlinico Roma Tor Vergata
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
San Filippo Neri Hospital
Roma, Italy
Sant'Eugenio Hospital
Roma, Italy
UOSD Tor Vergata
Roma, Italy
AOU Sassari
Sassari, Italy
Regional Hospital Treviso
Treviso, Italy
University Hospital of Trieste
Trieste, Italy
AOU Città della Salute e della Scienza
Turin, Italy
Mauriziano Hospital
Turin, Italy
ASST Vimercate
Vimercate, Italy
Related Publications (5)
Greenwood E, Swanton C. Consequences of COVID-19 for cancer care - a CRUK perspective. Nat Rev Clin Oncol. 2021 Jan;18(1):3-4. doi: 10.1038/s41571-020-00446-0.
PMID: 33097915RESULTJazieh AR, Akbulut H, Curigliano G, Rogado A, Alsharm AA, Razis ED, Mula-Hussain L, Errihani H, Khattak A, De Guzman RB, Mathias C, Alkaiyat MOF, Jradi H, Rolfo C; International Research Network on COVID-19 Impact on Cancer Care. Impact of the COVID-19 Pandemic on Cancer Care: A Global Collaborative Study. JCO Glob Oncol. 2020 Sep;6:1428-1438. doi: 10.1200/GO.20.00351.
PMID: 32986516RESULTTorzilli G, Vigano L, Galvanin J, Castoro C, Quagliuolo V, Spinelli A, Zerbi A, Donadon M, Montorsi M; COVID-SURGE-ITA group. A Snapshot of Elective Oncological Surgery in Italy During COVID-19 Emergency: Pearls, Pitfalls, and Perspectives. Ann Surg. 2020 Aug;272(2):e112-e117. doi: 10.1097/SLA.0000000000004081.
PMID: 32675512RESULTMitchell EP. Declines in Cancer Screening During COVID-19 Pandemic. J Natl Med Assoc. 2020 Dec;112(6):563-564. doi: 10.1016/j.jnma.2020.12.004. No abstract available.
PMID: 33339569RESULTOnder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available.
PMID: 32203977RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matteo Rottoli, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 13, 2021
First Posted
January 15, 2021
Study Start
September 8, 2020
Primary Completion
February 15, 2022
Study Completion
April 1, 2022
Last Updated
February 28, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share