Trial Outcomes & Findings for Ploidy and Stroma in Early Rectal Cancer (NCT NCT03039595)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

150 participants

Primary outcome timeframe

a minimum of 6 months after surgery

Results posted on

2022-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Patients All patients. This is an observational study; no interventions were used.
Overall Study STARTED	150
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients n=143 Participants All patients
Age, Continuous	69 years n=143 Participants
Sex: Female, Male Female	56 Participants n=143 Participants
Sex: Female, Male Male	87 Participants n=143 Participants
Region of Enrollment United Kingdom	143 participants n=143 Participants
Tumour stage pT1 (tumour confined to the inner layer of the bowel)	76 Participants n=143 Participants
Tumour stage pT2 (tumour extends into the muscle layer of the bowel wall)	58 Participants n=143 Participants
Tumour stage pT3 (tumour has reached the outer lining of the bowel wall)	9 Participants n=143 Participants
Post-TEM management Surveillance	88 Participants n=143 Participants
Post-TEM management Completion radical surgery	13 Participants n=143 Participants
Post-TEM management Adjuvant radiotherapy	42 Participants n=143 Participants

PRIMARY outcome

Timeframe: a minimum of 6 months after surgery

Population: Only patients for whom ploidy status was available were included in the analysis (ploidy assessment failed in 3 patients for technical reasons)

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

Outcome measures

Outcome measures
Measure	Patients n=140 Participants All patients
Correlation Between Ploidy Status With Local Recurrence of Cancer Diploid - Local recurrence	3 Participants
Correlation Between Ploidy Status With Local Recurrence of Cancer Diploid - No local recurrence	31 Participants
Correlation Between Ploidy Status With Local Recurrence of Cancer Non-diploid - Local recurrence	14 Participants
Correlation Between Ploidy Status With Local Recurrence of Cancer Non-diploid - No local recurrence	92 Participants

PRIMARY outcome

Timeframe: a minimum of 6 months after surgery

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.

Outcome measures

Outcome measures
Measure	Patients n=143 Participants All patients
Correlation Between Tumour: Stroma Ratio With Local Recurrence of Cancer High TSR - Local recurrence	2 Participants
Correlation Between Tumour: Stroma Ratio With Local Recurrence of Cancer High TSR - No local recurrence	9 Participants
Correlation Between Tumour: Stroma Ratio With Local Recurrence of Cancer Low TSR - Local recurrence	17 Participants
Correlation Between Tumour: Stroma Ratio With Local Recurrence of Cancer Low TSR - No local recurrence	115 Participants

SECONDARY outcome

Timeframe: a minimum of 6 months after surgery

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 between the test results and overall survival

Outcome measures

Outcome measures
Measure	Patients n=140 Participants All patients
Correlation Between Ploidy Status and Overall Survival After TEM Surgery to Remove Rectal Cancer Diploid - Alive	27 Participants
Correlation Between Ploidy Status and Overall Survival After TEM Surgery to Remove Rectal Cancer Diploid - Deceased	7 Participants
Correlation Between Ploidy Status and Overall Survival After TEM Surgery to Remove Rectal Cancer Non-diploid - Alive	86 Participants
Correlation Between Ploidy Status and Overall Survival After TEM Surgery to Remove Rectal Cancer Non-diploid - Deceased	20 Participants

SECONDARY outcome

Timeframe: a minimum of 6 months after surgery

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 between the test results and overall survival. High TSR is defined using a 50% cut-off.

Outcome measures

Outcome measures
Measure	Patients n=143 Participants All patients
Correlation Between Tumour:Stroma Ratio and Overall Survival After TEM Surgery to Remove Rectal Cancer High TSR - Alive	6 Participants
Correlation Between Tumour:Stroma Ratio and Overall Survival After TEM Surgery to Remove Rectal Cancer High TSR - Deceased	5 Participants
Correlation Between Tumour:Stroma Ratio and Overall Survival After TEM Surgery to Remove Rectal Cancer Low TSR - Alive	110 Participants
Correlation Between Tumour:Stroma Ratio and Overall Survival After TEM Surgery to Remove Rectal Cancer Low TSR - Deceased	22 Participants

Adverse Events

Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 27 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Helen Jones

Oxford Univeristy Hospitals NHS Foundation Trust

Phone: 01865 235657

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place