NCT03039595

Brief Summary

Early rectal cancer can be removed by minimally-invasive surgery, and the standard pathological assessment of the removed tumour gives valuable information about how advanced the tumour is. This gives an indication of how likely the cancer is to recur, so doctors and patient can decide on the most appropriate further treatment and follow-up. However there is still much uncertainty in these predictions about recurrence. This study will assess two further pathology tests, ploidy and stroma ratio in the tumour, by correlating the results with outcome. This will determine whether these two tests provide additional value in predicting outcome. If so, clinicians would be better able to advise patients with early rectal cancer about their prognosis and further management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 9, 2022

Completed
Last Updated

June 9, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

January 30, 2017

Results QC Date

January 10, 2022

Last Update Submit

March 9, 2022

Conditions

Rectal Cancer

Keywords

Early rectal cancerPloidyTumour:stroma ratio

Outcome Measures

Primary Outcomes (2)

  • Correlation Between Ploidy Status With Local Recurrence of Cancer

    Results of ploidy status will be correlated with patient follow-up information for between 6 months and 9 years following surgery, to look for any correlation with local recurrence of the rectal cancer

    a minimum of 6 months after surgery

  • Correlation Between Tumour: Stroma Ratio With Local Recurrence of Cancer

    Results of tumour:stromal ratio (TSR) will be correlated with patient follow-up information for between 6 months and 9 years following surgery, to look for any correlation with local recurrence of the rectal cancer. A 50% cut-off is used to define high TSR.

    a minimum of 6 months after surgery

Secondary Outcomes (2)

  • Correlation Between Ploidy Status and Overall Survival After TEM Surgery to Remove Rectal Cancer

    a minimum of 6 months after surgery

  • Correlation Between Tumour:Stroma Ratio and Overall Survival After TEM Surgery to Remove Rectal Cancer

    a minimum of 6 months after surgery

Interventions

Ploidy and tumour:stromal ratio measurementsOTHER

Ploidy and tumour:stromal ratio measurements will be made on specimens of early rectal cancer removed by transanal endoscopic microsurgery (TEM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants diagnosed with rectal cancer that is operable and patients who have already had rectal cancer removed by transanal endoscopic microsurgery (TEM) in Oxford since 2007.

You may qualify if:

  • Participant is willing and able to give informed consent (in English) for participation in the study, or gave informed consent for donation of tissue for research at the time of surgery
  • Male or Female, aged 18 years or above
  • Diagnosed with operable rectal cancer
  • Due to undergo, or has already undergone, TEM surgery to remove rectal cancer
  • A useable tissue sample has already been, or will be, taken as part of routine surgery

You may not qualify if:

  • Age less than 18
  • Adults who are not able to give consent or who are deemed vulnerable
  • Participants who do not have a useable tissue sample will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (6)

  • Bach SP, Hill J, Monson JR, Simson JN, Lane L, Merrie A, Warren B, Mortensen NJ; Association of Coloproctology of Great Britain and Ireland Transanal Endoscopic Microsurgery (TEM) Collaboration. A predictive model for local recurrence after transanal endoscopic microsurgery for rectal cancer. Br J Surg. 2009 Mar;96(3):280-90. doi: 10.1002/bjs.6456.

    PMID: 19224520BACKGROUND

  • Goh HS, Jass JR, Atkin WS, Cuzick J, Northover JM. Value of flow cytometric determination of ploidy as a guide to prognosis in operable rectal cancer: a multivariate analysis. Int J Colorectal Dis. 1987 Feb;2(1):17-21. doi: 10.1007/BF01648992.

    PMID: 3598327BACKGROUND

  • Kristensen GB, Kildal W, Abeler VM, Kaern J, Vergote I, Trope CG, Danielsen HE. Large-scale genomic instability predicts long-term outcome for women with invasive stage I ovarian cancer. Ann Oncol. 2003 Oct;14(10):1494-500. doi: 10.1093/annonc/mdg403.

    PMID: 14504048BACKGROUND

  • Park JH, Richards CH, McMillan DC, Horgan PG, Roxburgh CSD. The relationship between tumour stroma percentage, the tumour microenvironment and survival in patients with primary operable colorectal cancer. Ann Oncol. 2014 Mar;25(3):644-651. doi: 10.1093/annonc/mdt593. Epub 2014 Jan 23.

    PMID: 24458470BACKGROUND

  • Downey CL, Simpkins SA, White J, Holliday DL, Jones JL, Jordan LB, Kulka J, Pollock S, Rajan SS, Thygesen HH, Hanby AM, Speirs V. The prognostic significance of tumour-stroma ratio in oestrogen receptor-positive breast cancer. Br J Cancer. 2014 Apr 2;110(7):1744-7. doi: 10.1038/bjc.2014.69. Epub 2014 Feb 18.

    PMID: 24548861BACKGROUND

  • West NP, Dattani M, McShane P, Hutchins G, Grabsch J, Mueller W, Treanor D, Quirke P, Grabsch H. The proportion of tumour cells is an independent predictor for survival in colorectal cancer patients. Br J Cancer. 2010 May 11;102(10):1519-23. doi: 10.1038/sj.bjc.6605674. Epub 2010 Apr 20.

    PMID: 20407439BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens of early rectal cancer removed by transanal endoscopic microsurgery, which are routinely retained, will be further analysed.

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Ploidies

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Results Point of Contact

Title
Dr Helen Jones
Organization
Oxford Univeristy Hospitals NHS Foundation Trust
helen.jones3@ouh.nhs.uk
01865 235657

Study Officials

  • Chris Cunningham, MD

    Employee

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant colorectal surgeon

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 1, 2017

Study Start

March 29, 2017

Primary Completion

May 31, 2019

Study Completion

July 31, 2019

Last Updated

June 9, 2022

Results First Posted

June 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

No individual data will be made available

Locations

GB(1)