Colorectal Neoplasms MalignantCOVID-CRCNCT04712292
Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer
An observational study of Colorectal Neoplasms Malignant, run by University of Bologna at 45 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms Malignant
- What is being tested?
- Surgical procedure for confirmed or suspected colorectal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 15,000 participants
- Where
- 45 sitesItaly
- Study dates
- 8 Sep 2020to 1 Apr 2022
- 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: The study will include all adult patients undergoing elective or urgent surgery for proven or suspected colorectal within the study periods
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Italy45 sites, 45 recruiting
- Recruiting
AOU Policlinico di Bari "M. Rubino"
Bari
Gennaro Martines, MD, gerrymartines@virgilio.it
- Recruiting
Policlinico di Bari
Bari
Leonardo Vincenti, MD, dr.leonardo.vincenti@gmail.com
- Recruiting
Humanitas Gavazzeni Hospital
Bergamo
Giovanni Dapri, MD, giovanni@dapri.net
- Recruiting
Policlinico San Marco
Bergamo
Stefano Olmi, MD, stefano.olmi@gmail.com
- Recruiting
Maggiore Hospital
Bologna, 40100
Elio Jovine, MD, elio.jovine@ausl.bologna.it
- Recruiting
Fondazione Poliambulanza
Brescia
Moh'd Abu Hilal, MD, mohd.abuhilal@poliambulanza.it
- Recruiting
Spedali Civili
Brescia
Nazario Portolani, MD, nazario.portolani@unibs.it
- Recruiting
Spedali Civili
Brescia
Giusto Pignata, MD, giusto.pignata@gmail.com
- Recruiting
Santissima Trinità Hospital
Cagliari
Nicola Cillara, MD, ncillara@gmail.com
- Recruiting
Vittorio Emanuele III Hospital
Carate Brianza
Letizia Laface, MD, lafaceletizia@gmail.com
- Recruiting
San Paolo Hospital
Civitavecchia
Pasquale Lepiane, MD, pasquale.lepiane@aslroma4.it
- Recruiting
AUSL Romagna Ravenna-Faenza
Faenza
Giampaolo Ugolini, MD, g.ugolini@unibo.it
- Recruiting
San Giovanni di Dio Hospital
Florence
Giuseppe Canonico, MD, giuseppe.canonico@uslcentro.toscana.it
- Recruiting
Gardone Val Trompia Hospital
Gardone Val Trompia
Maurizio Ronconi, MD, maurizio.ronconi@asst-spedalicivili.it
- Recruiting
ASST FBF Sacco Hospital
Milan, 20100
Piergiorgio Danelli, MD, piergiorgio.danelli@unimi.it
- Recruiting
San Raffaele Hospital
Milan, 20100
Riccardo Rosati, MD, rosati.riccardo@hsr.it
- Recruiting
ASST Santi Paolo e Carlo Hospital
Milan
Enrico Opocher, MD, enrico.opocher@unimi.it
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milano
Milan
Luigi Boni, MD, luigi.boni@unimi.it
- Recruiting
Istituto Nazionale dei Tumori
Milan
Maurizio Cosimelli, MD, mcosimelli@libero.it
- Recruiting
Mirano Hospital
Mirano
Corrado Da Lio, MD, corrado.dalio@aulss3.veneto.it
- Recruiting
AORN Cardarelli
Naples
Antonio Castaldi, MD, antonio.castaldi@icloud.com
- Recruiting
Università della Campania Luigi Vanvitelli
Naples
Gianluca Pellino, MD, gianluca.pellino@unicampania.it
- Recruiting
Padova University Hospital
Padova
Salvatore Pucciarelli, MD, puc@unipd.it
- Recruiting
Veneto Institute of Oncology IOV-IRCCS
Padova
Pierluigi Pilati, MD, pierluigi.pilati@iov.veneto.it
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
Palermo
Marco V Marino, MD, Marco.Vito.marino@gmail.com
- Recruiting
AOU Parma
Parma
Mario Giuffrida, MD, mario.giuffrida4@gmail.com
- Recruiting
San Matteo Hospital
Pavia
Andrea Pietrabissa, MD, andrea.pietrabissa@gmail.com
- Recruiting
Pederzoli Hospital
Peschiera del Garda
Harmony Impellizzeri, MD, harmony85@hotmail.it
- Recruiting
Azienda Sanitaria Fiuli Occidentale
Pordenone
Stefano MM Basso, MD, drsteba@gmail.com
- Recruiting
Rho Memorial Hospital
Rho, Milan
Gianluca Sampietro, MD, gianluca.sampietro@unimi.it
- Recruiting
Ceccarini Hospital
Riccione
Andrea Lucchi, MD, andrea.lucchi@auslromagna.it
- Recruiting
Infermi Hospital
Rimini
Gianluca Garulli, MD, gianluca.garulli@auslromagna.it
- Recruiting
Campus Biomedico
Roma
Gabriella T Capolupo, MD, g.capolupo@unicampus.it
- Recruiting
Fondazione Policlinico Roma Tor Vergata
Roma
Giuseppe Sica, MD, sigisica@gmail.com
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Carlo Ratto, MD, carloratto@tiscali.it
- Recruiting
San Filippo Neri Hospital
Roma
Biagio Picardi, MD, biagiopicardi@gmail.com
- Recruiting
Sant'Eugenio Hospital
Roma
Massimo Carlini, MD, massimo.carlini@aslroma2.it
- Recruiting
UOSD Tor Vergata
Roma
Michela Campanelli, MD, michelacampanelli@live.it
- Recruiting
Humanitas Research Center
Rozzano, Milan, 40100
Antonino Spinelli, MD, antonino.spinelli@humanitas.it
- Recruiting
AOU Sassari
Sassari
Alberto Porcu, MD, alberto.porcu.1@gmail.com
- Recruiting
Regional Hospital Treviso
Treviso
Ugo Grossi, MD, ugo.grossi@aulss2.veneto.it
- Recruiting
University Hospital of Trieste
Trieste
Nicolò De Manzini, MD, ndemanzini@units.it
- Recruiting
AOU Città della Salute e della Scienza
Turin
Mario Morino, MD, mario.morino@unito.it
- Recruiting
Mauriziano Hospital
Turin
Alessandro Ferrero, MD, aferrero@mauriziano.it
- Recruiting
ASST Vimercate
Vimercate
Alice Frontali, MD, frontalice@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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. Italy witnessed a rapid and uncontrolled spread of the infection after March 2020, and a worrisome increasing number of related deaths.
The need for increased capacity for COVID-19 patients required elective activities to be drastically reduced or canceled. The unprecedented stress on the healthcare system has caused the reduction of the elective surgery and the cancer screening programs during the last 2 years. Studies predicting harmful impact of the COVID-19 pandemic on cancer care have been already published. However, it has not been proved whether the potential delay of screening, diagnosis and treatment could have a measurable effect on patients undergoing surgery for colorectal cancer in the COVID-19 era.
The aim of the study is therefore to compare the 30-day perioperative and oncologic outcomes between patients undergoing surgery for cancer of the colon and rectum between January 2020 and December 2021 (study group) and those who had surgery for colorectal cancer between January 2018 and December 2019 (Control Group), in order to identify:
- any change in the distribution of the histological stage (primary aim)
- any change in the rate of palliative surgery (primary aim)
- any change in the rate of non-radical surgery (R1 or R2 resection) ( primary aim)
- any change in the rate of 30-day postoperative complications (secondary outcome)
Anonimyzed data will be retrospectively collected on a RedCap platform hosted on the servers of the Alma Mater Studiorum University of Bologna. The variables included demographic characteristics, comorbidities, details of the disease at the diagnosis, details of the neoadjuvant therapy, perioperative variables and 30-day postoperative follow-up variables.
- Conditions
- Colorectal Neoplasms Malignant
- Being tested
- Surgical procedure for confirmed or suspected colorectal cancer
- Keywords
- colorectal cancer, diagnosis, screening, COVID-19, surgery, outcomes
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Disease, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedure for confirmed or suspected colorectal cancerProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2020 and December 2021 Receives: Procedure: Surgical procedure for confirmed or suspected colorectal cancer | |
| Control group | Patients undergoing surgery for confirmed or suspected colorectal cancer between January 2018 and December 2019 Receives: Procedure: Surgical procedure for confirmed or suspected colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncologic stage
The stage will be reported at the histological examination according to TNM classification
Measured: 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
Measured: 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
Measured: 30 days from surgery
Secondary outcomes (8)
Aggressive cancer biology
Biology was considered aggressive if any of the following characteristics were found at the histological examination: signet ring cells, mucinous tumor, tumor budding, lymphovascular invasion, perineurial invasion, lymphangitis.
Measured: 30 days from the surgery
Rate of clinical T4 cancer at the preoperative staging
Clinical T4 cancer are defined as those with high suspicious of local invasion of adjacent organs or structures, not necessary confirmed as T4 at the histological examination
Measured: At time 0 (surgery)
Liver metastases
Rate of single/multiple liver metastases
Measured: At the preoperative staging or at surgery (time 0)
Lung metastases
Rate of single/multiple lung metastases
Measured: At the preoperative staging or at surgery (time 0)
Associated symptoms
Rate of patients who had a diagnosis of cancer without any associated symptoms - as sign of effectiveness of the screening
Measured: Before surgery
Emergency surgery
rate of operations requiring surgery within 48 hours from the unpredicted admission to hospital
Measured: surgery (time 0)
Postoperative complications
Rate of 30-day complications graded according to the Clavien-Dindo Classification
Measured: 30 days from surgery
Mortality
Rate of 30-day deaths
Measured: 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start8 Sep 2020
- Primary completion15 Feb 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal Neoplasms MalignantStudies 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
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Rottoli, University of Bologna
- Investigators
- Matteo Rottoli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712292
- Sponsor's protocol ID
- 854/2020/Oss/AOUBo
- Acronym
- COVID-CRC
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33097915Jazieh 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.
PubMed 32986516Torzilli 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.
PubMed 32675512Mitchell 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.
PubMed 33339569Onder 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.
PubMed 32203977
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04712292
- Acronym / sponsor ID
- COVID-CRC / 854/2020/Oss/AOUBo
- Conditions
- Colorectal Neoplasms Malignant
- Keywords
- colorectal cancer, diagnosis, screening, COVID-19, surgery, outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 15 Jan 2021 (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.
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.
Detailed description
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. Italy witnessed a rapid and uncontrolled spread of the infection after March 2020, and a worrisome increasing number of related deaths.
The need for increased capacity for COVID-19 patients required elective activities to be drastically reduced or canceled. The unprecedented stress on the healthcare system has caused the reduction of the elective surgery and the cancer screening programs during the last 2 years. Studies predicting harmful impact of the COVID-19 pandemic on cancer care have been already published. However, it has not been proved whether the potential delay of screening, diagnosis and treatment could have a measurable effect on patients undergoing surgery for colorectal cancer in the COVID-19 era.
The aim of the study is therefore to compare the 30-day perioperative and oncologic outcomes between patients undergoing surgery for cancer of the colon and rectum between January 2020 and December 2021 (study group) and those who had surgery for colorectal cancer between January 2018 and December 2019 (Control Group), in order to identify:
- any change in the distribution of the histological stage (primary aim)
- any change in the rate of palliative surgery (primary aim)
- any change in the rate of non-radical surgery (R1 or R2 resection) ( primary aim)
- any change in the rate of 30-day postoperative complications (secondary outcome)
Anonimyzed data will be retrospectively collected on a RedCap platform hosted on the servers of the Alma Mater Studiorum University of Bologna. The variables included demographic characteristics, comorbidities, details of the disease at the diagnosis, details of the neoadjuvant therapy, perioperative variables and 30-day postoperative follow-up variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Surgical procedure for confirmed or suspected colorectal cancerPatients undergoing surgery for confirmed or suspected colorectal cancer between January 2020 and December 2021 |
| Control group | – | Procedure: Surgical procedure for confirmed or suspected colorectal cancerPatients undergoing surgery for confirmed or suspected colorectal cancer between January 2018 and December 2019 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include all adult patients undergoing elective or urgent surgery for proven or suspected colorectal within the study periods
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical procedure for confirmed or suspected colorectal cancerSurgical 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) | Procedure or surgery | Control group, Study group |
Primary outcome
Oncologic stage
Time frame: 30 days from the surgery
The stage will be reported at the histological examination according to TNM classification
Palliative surgery
Time frame: at time 0 (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
Rate of radical surgery
Time frame: 30 days from surgery
Surgery is defined radical according to the absence of cancer (R0) at the surgical margins on the histological specimen
8 secondary outcomes
Aggressive cancer biology
Time frame: 30 days from the surgery
Rate of clinical T4 cancer at the preoperative staging
Time frame: At time 0 (surgery)
Liver metastases
Time frame: At the preoperative staging or at surgery (time 0)
Lung metastases
Time frame: At the preoperative staging or at surgery (time 0)
Associated symptoms
Time frame: Before surgery
Emergency surgery
Time frame: surgery (time 0)
Postoperative complications
Time frame: 30 days from surgery
Mortality
Time frame: 30 days from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Results publication: PubMed 33097915Greenwood 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.
- Results publication: PubMed 32986516Jazieh 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.
- Results publication: PubMed 32675512Torzilli 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.
- Results publication: PubMed 33339569Mitchell 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.
- Results publication: PubMed 32203977Onder 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.
- 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.
Matteo Rottoli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Alma Mater Studiorum University of Bologna
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms Malignant, run by University of Bologna at 45 sites in Italy.
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 7 inclusion and 4 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 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Italy. 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 Matteo Rottoli, MD, PhD (+390512145262, matteo.rottoli2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncologic stage (time frame: 30 days from the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712292, which also lists 5 linked publications.
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 Feb 2022.