Advanced Pelvic Surgical Oncology Database - Prospective... | NCT05696002

Studies
Advanced Pelvic Surgical Oncology Database - Prospective Observational Study

NCT05696002

Sponsor

Glasgow Royal Infirmary

Status

Recruiting

Last Update Posted

Jan 25, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Rectal Cancer
Pelvic Cancer
Gynecologic Cancer
Colon Cancer

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2023Actual

Primary Completion Date

Jan 1, 2028Estimated

Completion Date

Jan 1, 2030Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Jan 13, 2023

First Posted Date

Jan 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2023

Last Update Posted Date

Jan 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Norman Galbraith, NES/CSO Clinical Lecturer in Surgery, Glasgow Royal InfirmaryPrincipal Investigator

Lead Sponsor

Glasgow Royal InfirmaryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.

Detailed Description

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study..

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Label	Type	Description	Intervention Names
Advanced pelvic oncological resection		Complex resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cancer-specific survival	Months	10 years
Overall survival	Months	10 years
Post-operative complications	Frequency	10 years
Quality of life (survey)	Score	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced pelvic oncological resection defined as more than 1 pelvic organ resected

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Tertiary referral centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Norman Galbraith, PhD MRCS	Contact	07449784948		norman.galbraith@glasgow.ac.uk
Colin Steele, PhD FRCS	Contact	07449784948		colin.steele@glasgow.ac.uk

Overall Officials

Name	Affiliation	Role
Colin Steele, PhD FRCS	Glasgow Royal Infirmary	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Department of Surgery, Glasgow Royal Infirmary	Recruiting	Glasgow			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D010386	Pelvic Neoplasms
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided