Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04712292
Other study ID # 854/2020/Oss/AOUBo
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2020
Est. completion date April 1, 2022

Study information

Verified date February 2022
Source University of Bologna
Contact Matteo Rottoli, MD, PhD
Phone +390512145262
Email matteo.rottoli2@unibo.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15000
Est. completion date April 1, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Procedure:
Surgical procedure for confirmed or suspected colorectal cancer
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)

Locations

Country Name City State
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
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 Firenze
Italy Gardone Val Trompia Hospital Gardone Val Trompia
Italy ASST FBF Sacco Hospital Milan
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 San Raffaele Hospital Milan
Italy Mirano Hospital Mirano
Italy AORN Cardarelli Napoli
Italy Università della Campania Luigi Vanvitelli Napoli
Italy Padova University Hospital Padova
Italy Veneto Institute of Oncology IOV-IRCCS Padova
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 Rho Memorial Hospital Rho Milan
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 Humanitas Research Center Rozzano Milan
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

Sponsors (1)

Lead Sponsor Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Jazieh 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 Pa — View Citation

Mitchell 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. — View Citation

Onder 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. Erratum in: JAMA. 2020 Apr 28;323(16):1619. — View Citation

Torzilli G, Viganò 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Oncologic stage The stage will be reported at the histological examination according to TNM classification 30 days from the surgery
Primary 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)
Primary 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 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. 30 days from the surgery
Secondary 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 At time 0 (surgery)
Secondary Liver metastases Rate of single/multiple liver metastases At the preoperative staging or at surgery (time 0)
Secondary Lung metastases Rate of single/multiple lung metastases At the preoperative staging or at surgery (time 0)
Secondary Associated symptoms Rate of patients who had a diagnosis of cancer without any associated symptoms - as sign of effectiveness of the screening Before surgery
Secondary Emergency surgery rate of operations requiring surgery within 48 hours from the unpredicted admission to hospital surgery (time 0)
Secondary Postoperative complications Rate of 30-day complications graded according to the Clavien-Dindo Classification 30 days from surgery
Secondary Mortality Rate of 30-day deaths 30 days from surgery
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03775980 - CIRSE Emprint Microwave Ablation Registry
Recruiting NCT05155124 - Safety of Cetuximab and Trifluridin Tipiracil as the Third-line Therapy in the RASwt mCRC Phase 1
Recruiting NCT06050447 - Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Active, not recruiting NCT03993626 - A Trial of CXD101 in Combination With Nivolumab in Patients With Metastatic Microsatellite-Stable Colorectal Cancer Phase 1/Phase 2
Recruiting NCT06314971 - Predicting Local and Distant Recurrence in T1 Colorectal Cancer
Recruiting NCT06342440 - Early Detection of Advanced Adenomas and Colorectal Cancer
Recruiting NCT05853094 - Postoperative Effects of Different Enterostomy Approaches N/A
Recruiting NCT06200831 - Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases N/A
Recruiting NCT02758951 - Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases Phase 2/Phase 3
Recruiting NCT03686254 - The Effects of RFA in Combination With Second-line Chemotherapy and Bevacizumab on Unresectable CRLM Phase 2/Phase 3
Recruiting NCT05278351 - Tislelizumab Plus Cetuximab and Irinotecan vs Third-line Standard-of-care in Refractory mCRC Phase 2
Terminated NCT04873895 - TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC) Phase 1
Completed NCT04002128 - Tracheal Colonization and Outcome After Major Abdominal Cancer Surgery N/A
Recruiting NCT06208371 - Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM Phase 3
Not yet recruiting NCT05129774 - Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM N/A
Completed NCT06410729 - Significance of Benign Lymph Node Enlargement in Colorectal Cancer
Completed NCT03507699 - Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT03581890 - Socioeconomic Position in Acute Colorectal Cancer Surgery
Recruiting NCT05138094 - LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection N/A
Recruiting NCT03191110 - The COLON Study: Colorectal Cancer Cohort