N/A
N=150
Ploidy and Stroma in Early Rectal Cancer
Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03039595 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Correlation Between Ploidy Status With Local Recurrence of Cancer — 3; 31; 14; 92 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ploidy and tumour:stromal ratio measurements (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oxford University Hospitals NHS Trust
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Ploidy Status With Local Recurrence of Cancer |
3; 31; 14; 92 | — |
| PRIMARY Correlation Between Tumour: Stroma Ratio With Local Recurrence of Cancer |
2; 9; 17; 115 | — |
| SECONDARY Correlation Between Ploidy Status and Overall Survival After TEM Surgery to Remove Rectal Cancer |
27; 7; 86; 20 | — |
| SECONDARY Correlation Between Tumour:Stroma Ratio and Overall Survival After TEM Surgery to Remove Rectal Cancer |
6; 5; 110; 22 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03039595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.