Gastric CancerNCT05130710
The Impact of COVID-19 Pandemic on Clinical Presentation and Staging of Gastric Cancer
An observational study of Gastric Cancer and COVID-19 Pandemic, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, COVID-19 Pandemic, Peritoneal Metastases
- What is being tested?
- staging laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 25 Feb 2020to 25 Feb 2021
- 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: All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study.
Who may be able to join
- All patients became candidates to undergo staging laparoscopy (SL) in order to investigate local and peritoneal invasion of the tumor based on National Comprehensive Cancer Network guideline for gastric cancer 2020.
Who cannot join
- Patients with following criteria were excluded from the study; radiological evidence of metastatic disease, current or previous history of chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study.
Read the detailed description
This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study. February 25th was the day Ministry of Health and Medical Education announced COVID-19 as a national disaster and set restrictive rules of social distancing. The control group consisted of the gastric cancer patients whom referred to Cancer Institute during February 25th and December 25th of 2019. So the investigators compared two groups of gastric cancer patients one in the era of COVID-19 pandemic and other group from previous year when there was no COVID-19.
Cancer Institute as the pioneer of cancer management in Iran set institutional regulation for hospitalization of cancer patients during COVID-19 pandemic with the primary goal of delivering the best available treatment as timely as possible. In order to achieve this, each patient regardless of cancer type must had proceeded these steps before elective hospitalization and during preoperative, operation and postoperative days:
- Prior to hospitalization, patients were referred to infectious disease clinic, where they were visited by attending infectious disease specialists who had fellowship in infectious disease of immunocompromised and transplanted patients. Every patient monitored for COVID-19 sign and symptoms and those with high susceptibility were examined utilizing spiral chest computed tomography scan (SCCT) and polymerase chain reaction (PCR) for SARS-CoV-2. If a patient had positive result of either SCCT or PCR, he/she was managed either in outpatient or inpatient setting for COVID-19 treatment based on national protocol and subsequent cancer management was postponed. If it was confirmed that patient is eligible for hospitalization and entering operation room, he/she was admitted to surgical oncology ward.
- During pre-operative days, all patients were hospitalized in single or double bed room, family members were not allowed to accompany except for under legal aged patient and those who need special attention because of the low performance status. All patients were educated about COVID-19 transmission routs and preventive measures and asked to respect social distancing, wear facial mask and wash hands using alcohol- based antiseptic formulas given. Each patient underwent daily monitoring for sign and symptoms of COVID-19, heart rate, blood pressure, temperature and oxygen saturation by commercially available pulse oximetry devices. In case of developing signs and symptoms related to COVID-19 or unexplained temperature > 38°C, oxygen saturation < 93% or > 5 unit drop in oxygen saturation from the baseline, infectious disease consultation was ordered.
- During operation time, the minimum number of personnel needed to activate a safe operation environment whom were fully equipped with personal preventive clothing including surgical cap, gown, facial mask and shield were present at the theater. The operation theater was well ventilated.
- During post-operative days, for both intensive care unit and ward patient, daily monitoring of signs and symptoms related to COVID-19 besides unexplained temperature > 38°C, oxygen saturation < 93% or > 5 unit drop in oxygen saturation from the baseline, C-Reactive Protein Level > 40 persistent for 3 days activated infectious disease consultation.
Patients of both case and control group were enrolled to the study as if they gave written consent of participation, had confirmed gastric cancer using esophago-gastro-duodenoscopy and pathologically proven biopsy and spiral thoraco-abdomino-pelvic computed tomography scan prior to surgery. All patients became candidates to undergo staging laparoscopy (SL) in order to investigate local and peritoneal invasion of the tumor based on National Comprehensive Cancer Network guideline for gastric cancer 2020. Patients with following criteria were excluded from the study; radiological evidence of metastatic disease, current or previous history of chemotherapy.
All patients of both groups underwent SL by the same two attending onco-surgeon, using the same technique and the same laparoscopic device. Under general anesthesia and in supine position SL was performed. A 10 mm optic laparoscopic port was inserted via the midline incision below the umbilicus using Hasson technique. All four quadrants of the abdomen as well as pelvis were inspected during laparoscopy and biopsy was taken from any suspicious lesion through insertion of 5mm port. All specimens underwent cytological evaluation by two independent pathologists. The presence of any malignant cells, regardless of the number, confirmed the positive cytology. In the event of discordant reports between two pathologists, specimens were sent for the third review by a pathologist who was blinded to the previous results. Laparoscopic evaluation was considered positive as if adjacent organ involvement, omental involvement or peritoneal seeding were seen.
Data were collected on the following variables: age, gender, tumor location, gastric lesion pathology and clinical stage based on the 8th edition of the American Joint Committee on Cancer tumor-node metastasis staging system for gastric cancer[16].
Categorical variables are shown as number and relative frequency. Also, continuous variables are shown as mean ± SD. Collected data for categorical variables were compared using the chi-squared test. An independent student t-test was used to compare means between the two groups. All analyses were performed by the two-sided method using Statistical Package of Social Science software (SPSS version 22; SPSS, Inc., Chicago, IL), and the p-value of < 0.05 was set as statistically significant.
- Conditions
- Gastric Cancer, COVID-19 Pandemic, Peritoneal Metastases
- Being tested
- staging laparoscopy
- Medical subject headings
- Stomach Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
staging laparoscopyProcedure or surgery
All patients of both groups underwent staging laparoscopy by the same two attending onco-surgeon, using the same technique and the same laparoscopic device. Under general anesthesia and in supine position SL was performed. A 10 mm optic laparoscopic port was inserted via the midline incision below the umbilicus using Hasson technique. All four quadrants of the abdomen as well as pelvis were inspected during laparoscopy and biopsy was taken from any suspicious lesion through insertion of 5mm port. All specimens underwent cytological evaluation by two independent pathologists. The presence of any malignant cells, regardless of the number, confirmed the positive cytology. In the event of discordant reports between two pathologists, specimens were sent for the third review by a pathologist who was blinded to the previous results. Laparoscopic evaluation was considered positive as if adjacent organ involvement, omental involvement or peritoneal seeding were seen.
| Study group | Role | What they receive |
|---|---|---|
| case | 26 patients with gastric cancer wo were referred to our center between February 25th to December 25th of 2020. Receives: Procedure: staging laparoscopy | |
| control | 54 patients with gastric cancer wo were referred to our center between February 25th to December 25th of 2019. Receives: Procedure: staging laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of peritoneal seeding
involvement of peritoneal cavity with metastatic gastric cancer.
Measured: February 25th and December 25th 2020
Secondary outcomes (1)
presence of peri-gastric lymph node involvement
involvement of peri-gastric lymph node with metastatic gastric cancer
Measured: February 25th and December 25th 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start25 Feb 2020
- Primary completion25 Dec 2020
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gastric 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130710
- Sponsor's protocol ID
- IR.TUMS.IKHC.REC.1399.414
- Status last verified
- Nov 2021
- First submitted
- 19 Nov 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be available up on reasonable request from Amirisina Sharifi.M.D.(a.s\_sharifi@yahoo.com).
Publications
Salari A, Jalaeefar A, Shirkhoda M. What is the best treatment option for head and neck cancers in COVID-19 pandemic? A rapid review. Am J Otolaryngol. 2020 Nov-Dec;41(6):102738. doi: 10.1016/j.amjoto.2020.102738. Epub 2020 Sep 18.
PubMed 32979663Di Fiore F, Bouche O, Lepage C, Sefrioui D, Gangloff A, Schwarz L, Tuech JJ, Aparicio T, Lecomte T, Boulagnon-Rombi C, Lievre A, Manfredi S, Phelip JM, Michel P; Thesaurus National de Cancerologie Digestive (TNCD); Societe Nationale Francaise de Gastroenterologie (SNFGE); Federation Francophone de Cancerologie Digestive (FFCD); Groupe Cooperateur multidisciplinaire en Oncologie (GERCOR); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Societe Francaise de Chirurgie Digestive (SFCD); Societe Francaise d'Endoscopie Digestive (SFED); Societe Francaise de Radiotherapie Oncologique (SFRO) and Societe Francaise de Radiologie (SFR); Association Chirurgie Hepato-Biliaire et Transplantation (ACHBT). COVID-19 epidemic: Proposed alternatives in the management of digestive cancers: A French intergroup clinical point of view (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, SFR). Dig Liver Dis. 2020 Jun;52(6):597-603. doi: 10.1016/j.dld.2020.03.031. Epub 2020 May 14.
PubMed 32418773Johnson BA, Waddimba AC, Ogola GO, Fleshman JW Jr, Preskitt JT. A systematic review and meta-analysis of surgery delays and survival in breast, lung and colon cancers: Implication for surgical triage during the COVID-19 pandemic. Am J Surg. 2021 Aug;222(2):311-318. doi: 10.1016/j.amjsurg.2020.12.015. Epub 2020 Dec 8.
PubMed 33317814Wu JT, Kwon DH, Glover MJ, Henry S, Wood D, Rubin DL, Koshkin VS, Schapira L, Shah SA. Changes in Cancer Management due to COVID-19 Illness in Patients with Cancer in Northern California. JCO Oncol Pract. 2021 Mar;17(3):e377-e385. doi: 10.1200/OP.20.00790. Epub 2020 Dec 17.
PubMed 33332170Zaniboni A, Ghidini M, Grossi F, Indini A, Trevisan F, Iaculli A, Dottorini L, Moleri G, Russo A, Vavassori I, Brevi A, Rausa E, Boni L, Dondossola D, Valeri N, Ghidini A, Tomasello G, Petrelli F. A Review of Clinical Practice Guidelines and Treatment Recommendations for Cancer Care in the COVID-19 Pandemic. Cancers (Basel). 2020 Aug 29;12(9):2452. doi: 10.3390/cancers12092452.
PubMed 32872421Chan JW, Lee VHF. Will the COVID Pandemic Lead to Uncounted Cancer Deaths in the Future? Int J Radiat Oncol Biol Phys. 2020 Oct 1;108(2):351-352. doi: 10.1016/j.ijrobp.2020.07.003. No abstract available.
PubMed 32890510Vanni G, Tazzioli G, Pellicciaro M, Materazzo M, Paolo O, Cattadori F, Combi F, Papi S, Pistolese CA, Cotesta M, Santori F, Caspi J, Chiaravalloti A, Muscoli S, Lombardo V, Grasso A, Caggiati L, Raselli R, Palli D, Altomare V, D'Angelillo RM, Palombi L, Buonomo OC. Delay in Breast Cancer Treatments During the First COVID-19 Lockdown. A Multicentric Analysis of 432 Patients. Anticancer Res. 2020 Dec;40(12):7119-7125. doi: 10.21873/anticanres.14741. Epub 2020 Dec 7.
PubMed 33288611Gundavda MK, Gundavda KK. Cancer or COVID-19? A Review of Guidelines for Safe Cancer Care in the Wake of the Pandemic. SN Compr Clin Med. 2020;2(12):2691-2701. doi: 10.1007/s42399-020-00632-2. Epub 2020 Nov 21.
PubMed 33251481Arpino G, De Angelis C, De Placido P, Pietroluongo E, Formisano L, Bianco R, Fiore G, Montella E, Forestieri V, Lauria R, Cardalesi C, Vozzella EA, Iervolino A, Giuliano M, De Placido S. Optimising triage procedures for patients with cancer needing active anticancer treatment in the COVID-19 era. ESMO Open. 2020 Sep;5(5):e000885. doi: 10.1136/esmoopen-2020-000885.
PubMed 32958531
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COVID-19 Pandemic on Clinical Presentation and Staging of Gastric Cancer
- ClinicalTrials.gov ID
- NCT05130710
- Acronym / sponsor ID
- IR.TUMS.IKHC.REC.1399.414
- Conditions
- Gastric Cancer, COVID-19 Pandemic, Peritoneal Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 23 Nov 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.
This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study.
Detailed description
This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study. February 25th was the day Ministry of Health and Medical Education announced COVID-19 as a national disaster and set restrictive rules of social distancing. The control group consisted of the gastric cancer patients whom referred to Cancer Institute during February 25th and December 25th of 2019. So the investigators compared two groups of gastric cancer patients one in the era of COVID-19 pandemic and other group from previous year when there was no COVID-19.
Cancer Institute as the pioneer of cancer management in Iran set institutional regulation for hospitalization of cancer patients during COVID-19 pandemic with the primary goal of delivering the best available treatment as timely as possible. In order to achieve this, each patient regardless of cancer type must had proceeded these steps before elective hospitalization and during preoperative, operation and postoperative days:
- Prior to hospitalization, patients were referred to infectious disease clinic, where they were visited by attending infectious disease specialists who had fellowship in infectious disease of immunocompromised and transplanted patients. Every patient monitored for COVID-19 sign and symptoms and those with high susceptibility were examined utilizing spiral chest computed tomography scan (SCCT) and polymerase chain reaction (PCR) for SARS-CoV-2. If a patient had positive result of either SCCT or PCR, he/she was managed either in outpatient or inpatient setting for COVID-19 treatment based on national protocol and subsequent cancer management was postponed. If it was confirmed that patient is eligible for hospitalization and entering operation room, he/she was admitted to surgical oncology ward.
- During pre-operative days, all patients were hospitalized in single or double bed room, family members were not allowed to accompany except for under legal aged patient and those who need special attention because of the low performance status. All patients were educated about COVID-19 transmission routs and preventive measures and asked to respect social distancing, wear facial mask and wash hands using alcohol- based antiseptic formulas given. Each patient underwent daily monitoring for sign and symptoms of COVID-19, heart rate, blood pressure, temperature and oxygen saturation by commercially available pulse oximetry devices. In case of developing signs and symptoms related to COVID-19 or unexplained temperature > 38°C, oxygen saturation < 93% or > 5 unit drop in oxygen saturation from the baseline, infectious disease consultation was ordered.
- During operation time, the minimum number of personnel needed to activate a safe operation environment whom were fully equipped with personal preventive clothing including surgical cap, gown, facial mask and shield were present at the theater. The operation theater was well ventilated.
- During post-operative days, for both intensive care unit and ward patient, daily monitoring of signs and symptoms related to COVID-19 besides unexplained temperature > 38°C, oxygen saturation < 93% or > 5 unit drop in oxygen saturation from the baseline, C-Reactive Protein Level > 40 persistent for 3 days activated infectious disease consultation.
Patients of both case and control group were enrolled to the study as if they gave written consent of participation, had confirmed gastric cancer using esophago-gastro-duodenoscopy and pathologically proven biopsy and spiral thoraco-abdomino-pelvic computed tomography scan prior to surgery. All patients became candidates to undergo staging laparoscopy (SL) in order to investigate local and peritoneal invasion of the tumor based on National Comprehensive Cancer Network guideline for gastric cancer 2020. Patients with following criteria were excluded from the study; radiological evidence of metastatic disease, current or previous history of chemotherapy.
All patients of both groups underwent SL by the same two attending onco-surgeon, using the same technique and the same laparoscopic device. Under general anesthesia and in supine position SL was performed. A 10 mm optic laparoscopic port was inserted via the midline incision below the umbilicus using Hasson technique. All four quadrants of the abdomen as well as pelvis were inspected during laparoscopy and biopsy was taken from any suspicious lesion through insertion of 5mm port. All specimens underwent cytological evaluation by two independent pathologists. The presence of any malignant cells, regardless of the number, confirmed the positive cytology. In the event of discordant reports between two pathologists, specimens were sent for the third review by a pathologist who was blinded to the previous results. Laparoscopic evaluation was considered positive as if adjacent organ involvement, omental involvement or peritoneal seeding were seen.
Data were collected on the following variables: age, gender, tumor location, gastric lesion pathology and clinical stage based on the 8th edition of the American Joint Committee on Cancer tumor-node metastasis staging system for gastric cancer[16].
Categorical variables are shown as number and relative frequency. Also, continuous variables are shown as mean ± SD. Collected data for categorical variables were compared using the chi-squared test. An independent student t-test was used to compare means between the two groups. All analyses were performed by the two-sided method using Statistical Package of Social Science software (SPSS version 22; SPSS, Inc., Chicago, IL), and the p-value of < 0.05 was set as statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Procedure: staging laparoscopy26 patients with gastric cancer wo were referred to our center between February 25th to December 25th of 2020. |
| control | – | Procedure: staging laparoscopy54 patients with gastric cancer wo were referred to our center between February 25th to December 25th of 2019. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study.
Key inclusion criteria (1 listed)
- All patients became candidates to undergo staging laparoscopy (SL) in order to investigate local and peritoneal invasion of the tumor based on National Comprehensive Cancer Network guideline for gastric cancer 2020.
Key exclusion criteria (1 listed)
- Patients with following criteria were excluded from the study; radiological evidence of metastatic disease, current or previous history of chemotherapy.
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 |
|---|---|---|
| staging laparoscopyAll patients of both groups underwent staging laparoscopy by the same two attending onco-surgeon, using the same technique and the same laparoscopic device. Under general anesthesia and in supine position SL was performed. A 10 mm optic laparoscopic port was inserted via the midline incision below the umbilicus using Hasson technique. All four quadrants of the abdomen as well as pelvis were inspected during laparoscopy and biopsy was taken from any suspicious lesion through insertion of 5mm port. All specimens underwent cytological evaluation by two independent pathologists. The presence of any malignant cells, regardless of the number, confirmed the positive cytology. In the event of discordant reports between two pathologists, specimens were sent for the third review by a pathologist who was blinded to the previous results. Laparoscopic evaluation was considered positive as if adjacent organ involvement, omental involvement or peritoneal seeding were seen. | Procedure or surgery | case, control |
Primary outcome
presence of peritoneal seeding
Time frame: February 25th and December 25th 2020
involvement of peritoneal cavity with metastatic gastric cancer.
1 secondary outcome
presence of peri-gastric lymph node involvement
Time frame: February 25th and December 25th 2020
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 23 Dec 2021.
- Background: PubMed 32979663Salari A, Jalaeefar A, Shirkhoda M. What is the best treatment option for head and neck cancers in COVID-19 pandemic? A rapid review. Am J Otolaryngol. 2020 Nov-Dec;41(6):102738. doi: 10.1016/j.amjoto.2020.102738. Epub 2020 Sep 18.
- Background: PubMed 32418773Di Fiore F, Bouche O, Lepage C, Sefrioui D, Gangloff A, Schwarz L, Tuech JJ, Aparicio T, Lecomte T, Boulagnon-Rombi C, Lievre A, Manfredi S, Phelip JM, Michel P; Thesaurus National de Cancerologie Digestive (TNCD); Societe Nationale Francaise de Gastroenterologie (SNFGE); Federation Francophone de Cancerologie Digestive (FFCD); Groupe Cooperateur multidisciplinaire en Oncologie (GERCOR); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Societe Francaise de Chirurgie Digestive (SFCD); Societe Francaise d'Endoscopie Digestive (SFED); Societe Francaise de Radiotherapie Oncologique (SFRO) and Societe Francaise de Radiologie (SFR); Association Chirurgie Hepato-Biliaire et Transplantation (ACHBT). COVID-19 epidemic: Proposed alternatives in the management of digestive cancers: A French intergroup clinical point of view (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, SFR). Dig Liver Dis. 2020 Jun;52(6):597-603. doi: 10.1016/j.dld.2020.03.031. Epub 2020 May 14.
- Background: PubMed 33317814Johnson BA, Waddimba AC, Ogola GO, Fleshman JW Jr, Preskitt JT. A systematic review and meta-analysis of surgery delays and survival in breast, lung and colon cancers: Implication for surgical triage during the COVID-19 pandemic. Am J Surg. 2021 Aug;222(2):311-318. doi: 10.1016/j.amjsurg.2020.12.015. Epub 2020 Dec 8.
- Background: PubMed 33332170Wu JT, Kwon DH, Glover MJ, Henry S, Wood D, Rubin DL, Koshkin VS, Schapira L, Shah SA. Changes in Cancer Management due to COVID-19 Illness in Patients with Cancer in Northern California. JCO Oncol Pract. 2021 Mar;17(3):e377-e385. doi: 10.1200/OP.20.00790. Epub 2020 Dec 17.
- Background: PubMed 32872421Zaniboni A, Ghidini M, Grossi F, Indini A, Trevisan F, Iaculli A, Dottorini L, Moleri G, Russo A, Vavassori I, Brevi A, Rausa E, Boni L, Dondossola D, Valeri N, Ghidini A, Tomasello G, Petrelli F. A Review of Clinical Practice Guidelines and Treatment Recommendations for Cancer Care in the COVID-19 Pandemic. Cancers (Basel). 2020 Aug 29;12(9):2452. doi: 10.3390/cancers12092452.
- Background: PubMed 32890510Chan JW, Lee VHF. Will the COVID Pandemic Lead to Uncounted Cancer Deaths in the Future? Int J Radiat Oncol Biol Phys. 2020 Oct 1;108(2):351-352. doi: 10.1016/j.ijrobp.2020.07.003. No abstract available.
- Background: PubMed 33288611Vanni G, Tazzioli G, Pellicciaro M, Materazzo M, Paolo O, Cattadori F, Combi F, Papi S, Pistolese CA, Cotesta M, Santori F, Caspi J, Chiaravalloti A, Muscoli S, Lombardo V, Grasso A, Caggiati L, Raselli R, Palli D, Altomare V, D'Angelillo RM, Palombi L, Buonomo OC. Delay in Breast Cancer Treatments During the First COVID-19 Lockdown. A Multicentric Analysis of 432 Patients. Anticancer Res. 2020 Dec;40(12):7119-7125. doi: 10.21873/anticanres.14741. Epub 2020 Dec 7.
- Background: PubMed 33251481Gundavda MK, Gundavda KK. Cancer or COVID-19? A Review of Guidelines for Safe Cancer Care in the Wake of the Pandemic. SN Compr Clin Med. 2020;2(12):2691-2701. doi: 10.1007/s42399-020-00632-2. Epub 2020 Nov 21.
- Background: PubMed 32958531Arpino G, De Angelis C, De Placido P, Pietroluongo E, Formisano L, Bianco R, Fiore G, Montella E, Forestieri V, Lauria R, Cardalesi C, Vozzella EA, Iervolino A, Giuliano M, De Placido S. Optimising triage procedures for patients with cancer needing active anticancer treatment in the COVID-19 era. ESMO Open. 2020 Sep;5(5):e000885. doi: 10.1136/esmoopen-2020-000885.
- Individual participant dataSharing planned: Yes. data will be available up on reasonable request from Amirisina Sharifi.M.D.(a.s_sharifi@yahoo.com).
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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.
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 Gastric Cancer and COVID-19 Pandemic, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 23 Dec 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 Iran. 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?
presence of peritoneal seeding (time frame: February 25th and December 25th 2020). 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 NCT05130710, which also lists 9 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 23 Dec 2021.