Brief Summary

This study aims to establish whether tumour markers measured from cytological samples can improve cervical cancer detection both prior to treatment and after treatment during follow up. All patients with presumed early cervical cancer referred to the Gynaecological Oncology Unit at The Royal Marsden Hospital and patients previously surgically treated for early cervical cancer with a suspected recurrence will be invited to participate. Women attending the Colposcopy Unit at St George's Hospital, with a normal cervix will be invited to participate. An endovaginal receiver coil has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS Foundation Trust for use at high field strengths (3T). A cytology swab, similar to a smear test, will be used to collect a sample of cells to evaluate the presence of tumour markers. The presence of tumour markers will be measured by a lab-on-a-chip and polymerase chain reaction (PCR) testing system.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Apr 2018

Status

unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

December 15, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed

3 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed

Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

1.4 years

First QC Date

December 15, 2017

Last Update Submit

December 15, 2017

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

Lab-on-a-chip agreement with PCR system
To compare the agreement (sensitivity/specificity) between lab-on-a-chip system and PCR system in detecting tumour markers (HPV and cancer-specific gene overexpression) derived from patients with biopsy/cytology proven i) primary and ii) recurrent squamous or adeno cervical cancer and those from cytologically normal cervix.
20 months

Secondary Outcomes (3)

Primary disease
20 months
Recurrent disease
20 months
Exploratory radiomic outcome
20 months