Breast NeoplasmsGS3NCT03471494
GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery
An observational study of Breast Neoplasms and Gastric Cancer, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Aim The aim is to determine the variation in quality of cancer surgery worldwide. Quality will be determined using measures covering infrastructure, care processes, and outcomes. The study will concentrate on the most common surgically treated cancers worldwide: breast, gastric and colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Gastric Cancer, Colon Cancer
- What is being tested?
- Exposure: human development index of country
- How many people
- 15,958 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 23 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective or emergency surgery for breast, gastric, or colorectal cancer anywhere in the world are eligible.
Who may be able to join
- All consecutive patients undergoing therapeutic surgery (curative or palliative) for breast, gastric, and colorectal cancer should be included.
- Surgery is defined as a procedure requiring a skin incision performed under general or neuraxial (e.g. regional, epidural or spinal) anaesthesia.
- Both elective and emergency procedures should be included. Include patients in whom the pre-operative diagnosis was thought to be benign, but was subsequently found to be cancer, e.g. bowel obstruction found to be due to cancer during surgery.
- Include patients in whom the pre-operative diagnosis was thought to be cancer, but was subsequently found to be benign disease (ensure the "pathology" variable indicates not cancer; will not be included in primary analysis).
- Laparoscopic, laparoscopic-converted, robotic, and open cases should be included.
- Patients aged 18 years and over should be included .
- Surgery may be with curative or palliative intent. Include patients in whom curative surgery was attempted but abandoned, e.g. open/close laparotomy.
Who cannot join
- Operations where breast, gastric, or colorectal cancer is not suspected to be the primary pathology should be excluded.
- Patients undergoing a procedure purely for diagnosis or staging should be excluded, e.g. open breast biopsy, staging laparoscopy.
- Patients undergoing a procedure which does not require a skin incision should be excluded, e.g. colonoscopy/endoscopy alone, chemo/radiotherapy alone.
- Patients presenting with recurrence of breast, colorectal or gastric cancer should be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Aim The aim is to determine the variation in quality of cancer surgery worldwide. Quality will be determined using measures covering infrastructure, care processes, and outcomes. The study will concentrate on the most common surgically treated cancers worldwide: breast, gastric and colorectal cancer. The primary aim focusses on 30-day mortality and complication rates after cancer surgery. The secondary aim is to characterise infrastructure and care processes in the treatment of these cancers worldwide.
Primary outcome measure 30-day mortality and complication rates after cancer surgery.
Read more
Primary comparison Between country groups defined by human development index.
Hospital eligibility Any hospital in the world performing surgery for breast, gastric or colorectal cancer.
Patient eligibility Consecutive patients undergoing surgery for breast, gastric, or colorectal cancer. Surgery can be with palliative or curative intent.
Team Individual hospital teams with up to three people, collecting data for four weeks. Several teams collecting data over multiple four-week periods is encouraged.
Time period Patients will be identified, and data collected on all patients during the time-period with follow-up to 30-days. The study will run from 1st April 2018 to 31st October 2018 (with follow-up of the last period to 30th November 2018).
Validation Data validation will be in two parts. First, centres will self-report the key processes used to identify and follow-up patients. Second, independent validators will quantitatively report case ascertainment and sampled data accuracy.
- Conditions
- Breast Neoplasms, Gastric Cancer, Colon Cancer
- Being tested
- Exposure: human development index of country
- Keywords
- Surgery, Quality, Outcomes
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: human development index of countryOther
Primary comparison: Between country groups defined by human development index.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer | Not described Receives: Other: Exposure: human development index of country | |
| Gastric cancer | Not described Receives: Other: Exposure: human development index of country | |
| Colon cancer | Not described Receives: Other: Exposure: human development index of country |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality rate
Death within 30 days of surgical procedure
Measured: 30 days from surgery
30-day complication rate
Defined with by Clavien-Dindo grade III or IV
Measured: 30 days from surgery
Secondary outcomes (21)
Availability/performance of pre-operative fine needle aspiration/core biopsy to diagnose breast cancer.
For breast cancer.
Measured: Prior to surgery.
Availability/performance of breast/axillary MRI for staging.
For breast cancer.
Measured: Prior to surgery.
Availability/performance of breast conservation surgery for AJCC stage 0/I/II breast cancer.
For breast cancer.
Measured: Prior to surgery.
Availability/ performance of axillary/breast radiotherapy and axillary lymph node clearance.
For breast cancer.
Measured: Collection of variable within 30 days of surgery.
Availability/performance of sentinel lymph-node biopsy for early invasive breast cancer.
For breast cancer.
Measured: During surgery.
Availability/performance of progesterone receptor (PR), oestrogen receptor (ER), human epidermal growth factor receptor 2 (HER2) receptor and Ki67 status for invasive cancers.
For breast cancer.
Measured: Prior to surgery.
Availability/treatment with adjuvant treatment where appropriate within 31 days of completion of surgery.
For breast cancer.
Measured: Within 31 days of completion of surgery.
Availability/plan for radiotherapy for all with breast conserving surgery with clear margins (including DCIS).
For breast cancer.
Measured: Collection of variable within 30 days of surgery.
Margin involvement. "Tumour on inked margin" is considered positive (SSO/ASTRO consensus guidelines) in surgery for early stage breast cancer or a margin <2 mm in DCIS [or ability to measure this locally].
For breast cancer.
Measured: Collection of variable within 30 days of surgery.
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging.
For gastric cancer.
Measured: Prior to surgery.
Availability/treatment with pre- or post-operative chemotherapy for gastric cancer.
For gastric cancer.
Measured: Prior to surgery.
Treatment decisions made within multidisciplinary team meeting / tumour board.
For gastric cancer.
Measured: Prior to surgery.
At least 15 regional lymph nodes removed and pathologically examined for resected gastric cancer [or ability to measure this locally].
For gastric cancer.
Measured: Collection of variable within 30 days of surgery.
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging.
For colon cancer.
Measured: Prior to surgery.
Availability/performance of pre-operative MRI for rectal cancer.
For colon cancer.
Measured: Prior to surgery.
Availability/planning/treatment with post-operative chemotherapy following resection for lymph node positive colon cancer.
For colon cancer.
Measured: Collection of variable within 30 days of surgery.
Availability/treatment with pre-operative chemotherapy/radiotherapy.
For colon cancer.
Measured: Prior to surgery.
Treatment decisions made within multidisciplinary team meeting / tumour board.
For colon cancer.
Measured: Prior to surgery.
Stoma formation rate.
For colon cancer.
Measured: During surgery.
Circumferential resection margin (CRM) >1mm [or ability to measure this locally].
For colon cancer.
Measured: Collection of variable within 30 days of surgery.
At least 12 regional lymph nodes removed and pathologically examined for resected colon cancer [or ability to measure this locally].
For colon cancer.
Measured: Collection of variable within 30 days of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Apr 2018
- Primary completion31 Oct 2018
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 15,958 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471494
- Sponsor's protocol ID
- GS3
- Acronym
- GS3
- Status last verified
- Jun 2024
- First submitted
- 9 Mar 2018
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Derived anonymised data at the patient-level may be able to be made available for sharing.
Publications
GlobalSurg Collaborative and National Institute for Health Research Global Health Research Unit on Global Surgery. Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries. Lancet. 2021 Jan 30;397(10272):387-397. doi: 10.1016/S0140-6736(21)00001-5. Epub 2021 Jan 21.
PubMed 33485461NIHR Global Health Research Uniton Global Surgery. Quality and outcomes in global cancer surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 3). BMJ Open. 2019 May 24;9(5):e026646. doi: 10.1136/bmjopen-2018-026646.
PubMed 31129582
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery
- ClinicalTrials.gov ID
- NCT03471494
- Acronym / sponsor ID
- GS3 / GS3
- Conditions
- Breast Neoplasms, Gastric Cancer, Colon Cancer
- Keywords
- Surgery, Quality, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,958 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 20 Mar 2018 (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.
Aim The aim is to determine the variation in quality of cancer surgery worldwide. Quality will be determined using measures covering infrastructure, care processes, and outcomes. The study will concentrate on the most common surgically treated cancers worldwide: breast, gastric and colorectal cancer. The primary aim focusses on 30-day mortality and complication rates after cancer surgery. The secondary aim is to characterise infrastructure and care processes in the treatment of these cancers worldwide.
Primary outcome measure 30-day mortality and complication rates after cancer surgery.
Primary comparison Between country groups defined by human development index.
Hospital eligibility Any hospital in the world performing surgery for breast, gastric or colorectal cancer.
Patient eligibility Consecutive patients undergoing surgery for breast, gastric, or colorectal cancer. Surgery can be with palliative or curative intent.
Team Individual hospital teams with up to three people, collecting data for four weeks. Several teams collecting data over multiple four-week periods is encouraged.
Time period Patients will be identified, and data collected on all patients during the time-period with follow-up to 30-days. The study will run from 1st April 2018 to 31st October 2018 (with follow-up of the last period to 30th November 2018).
Validation Data validation will be in two parts. First, centres will self-report the key processes used to identify and follow-up patients. Second, independent validators will quantitatively report case ascertainment and sampled data accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast cancer | – | Other: Exposure: human development index of country |
| Gastric cancer | – | Other: Exposure: human development index of country |
| Colon cancer | – | Other: Exposure: human development index of country |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective or emergency surgery for breast, gastric, or colorectal cancer anywhere in the world are eligible.
Key inclusion criteria (7 listed)
- All consecutive patients undergoing therapeutic surgery (curative or palliative) for breast, gastric, and colorectal cancer should be included.
- Surgery is defined as a procedure requiring a skin incision performed under general or neuraxial (e.g. regional, epidural or spinal) anaesthesia.
- Both elective and emergency procedures should be included. Include patients in whom the pre-operative diagnosis was thought to be benign, but was subsequently found to be cancer, e.g. bowel obstruction found to be due to cancer during surgery.
- Include patients in whom the pre-operative diagnosis was thought to be cancer, but was subsequently found to be benign disease (ensure the "pathology" variable indicates not cancer; will not be included in primary analysis).
- Laparoscopic, laparoscopic-converted, robotic, and open cases should be included.
Key exclusion criteria (4 listed)
- Operations where breast, gastric, or colorectal cancer is not suspected to be the primary pathology should be excluded.
- Patients undergoing a procedure purely for diagnosis or staging should be excluded, e.g. open breast biopsy, staging laparoscopy.
- Patients undergoing a procedure which does not require a skin incision should be excluded, e.g. colonoscopy/endoscopy alone, chemo/radiotherapy alone.
- Patients presenting with recurrence of breast, colorectal or gastric cancer should be excluded.
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 |
|---|---|---|
| Exposure: human development index of countryPrimary comparison: Between country groups defined by human development index. | Other | Breast cancer, Colon cancer, Gastric cancer |
Primary outcome
30-day mortality rate
Time frame: 30 days from surgery
Death within 30 days of surgical procedure
30-day complication rate
Time frame: 30 days from surgery
Defined with by Clavien-Dindo grade III or IV
21 secondary outcomes
Availability/performance of pre-operative fine needle aspiration/core biopsy to diagnose breast cancer.
Time frame: Prior to surgery.
Availability/performance of breast/axillary MRI for staging.
Time frame: Prior to surgery.
Availability/performance of breast conservation surgery for AJCC stage 0/I/II breast cancer.
Time frame: Prior to surgery.
Availability/ performance of axillary/breast radiotherapy and axillary lymph node clearance.
Time frame: Collection of variable within 30 days of surgery.
Availability/performance of sentinel lymph-node biopsy for early invasive breast cancer.
Time frame: During surgery.
Availability/performance of progesterone receptor (PR), oestrogen receptor (ER), human epidermal growth factor receptor 2 (HER2) receptor and Ki67 status for invasive cancers.
Time frame: Prior to surgery.
Availability/treatment with adjuvant treatment where appropriate within 31 days of completion of surgery.
Time frame: Within 31 days of completion of surgery.
Availability/plan for radiotherapy for all with breast conserving surgery with clear margins (including DCIS).
Time frame: Collection of variable within 30 days of surgery.
Margin involvement. "Tumour on inked margin" is considered positive (SSO/ASTRO consensus guidelines) in surgery for early stage breast cancer or a margin <2 mm in DCIS [or ability to measure this locally].
Time frame: Collection of variable within 30 days of surgery.
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging.
Time frame: Prior to surgery.
Availability/treatment with pre- or post-operative chemotherapy for gastric cancer.
Time frame: Prior to surgery.
Treatment decisions made within multidisciplinary team meeting / tumour board.
Time frame: Prior to surgery.
At least 15 regional lymph nodes removed and pathologically examined for resected gastric cancer [or ability to measure this locally].
Time frame: Collection of variable within 30 days of surgery.
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging.
Time frame: Prior to surgery.
Availability/performance of pre-operative MRI for rectal cancer.
Time frame: Prior to surgery.
Availability/planning/treatment with post-operative chemotherapy following resection for lymph node positive colon cancer.
Time frame: Collection of variable within 30 days of surgery.
Availability/treatment with pre-operative chemotherapy/radiotherapy.
Time frame: Prior to surgery.
Treatment decisions made within multidisciplinary team meeting / tumour board.
Time frame: Prior to surgery.
Stoma formation rate.
Time frame: During surgery.
Circumferential resection margin (CRM) >1mm [or ability to measure this locally].
Time frame: Collection of variable within 30 days of surgery.
At least 12 regional lymph nodes removed and pathologically examined for resected colon cancer [or ability to measure this locally].
Time frame: Collection of variable within 30 days of 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 7 Jun 2024.
- Derived from this study: PubMed 33485461GlobalSurg Collaborative and National Institute for Health Research Global Health Research Unit on Global Surgery. Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries. Lancet. 2021 Jan 30;397(10272):387-397. doi: 10.1016/S0140-6736(21)00001-5. Epub 2021 Jan 21.
- Derived from this study: PubMed 31129582NIHR Global Health Research Uniton Global Surgery. Quality and outcomes in global cancer surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 3). BMJ Open. 2019 May 24;9(5):e026646. doi: 10.1136/bmjopen-2018-026646.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Derived anonymised data at the patient-level may be able to be made available for sharing.
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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 Breast Neoplasms and Gastric Cancer, run by University of Edinburgh at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 7 Jun 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 United Kingdom. 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?
30-day mortality rate (time frame: 30 days from surgery). The study lists 2 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 NCT03471494, which also lists 2 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 7 Jun 2024.