Cervical CancerMODULARNCT03380741
Lab-on-a-chip Detection of Cervical Cancer Tumour Markers
An observational study of Cervical Cancer, run by Royal Marsden NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Tumour markers detection
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with presumed early cervical cancer referred to the Gynaecological Oncology Units at The Royal Marsden Hospital and patients previously surgically treated for early cervical cancer currently undergoing follow up with suspected cancer recurrence will be invited to participate. Women attending St George's Hospital colposcopy clinic, who are judged to have a normal cervix on colposcopy examination will be invited to participate.
Who may be able to join
- • Patients with presumed early stage cervical cancer (squamous or adenocarcinoma on histology) being considered for curative surgery.
- Patients treated surgically for cervical cancer (squamous or adenocarcinoma on histology) being followed-up for suspected recurrent disease.
- Patients with normal cervix at colposcopy examination.
Who cannot join
- Ferromagnetic metal implants, claustrophobia (MRI incompatibility). Neuroendocrine or unusual histological subtypes. Abnormal cervix seen at colposcopy examination (for Normal cervix cohort).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Molecular Diagnostics Using a Novel Lab-on-a-chip and MRI for Detecting Cervical Cancer
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.
Read more
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.
Read the detailed description
Cervical cytology: This will be done prior to MRI at an out-patient visit or at the scan visit in all study subjects with cancer. IN those patients with a normal cervix at colposcopy, the sample will be taken as part of the colposcopy examination. The procedure will be identical to that used for cervical smear testing and involves the insertion of a speculum and taking a swab from the cervix and/ or vaginal vault for tumour marker assessment on lab-on-a-chip. Additionally, the sample will be examined conventionally to assess cytology.
MRI scan: For patients with primary disease, this will be done using an endovaginal technique. A ring design endovaginal coil will be inserted endovaginally around the cervix. It acts as a dedicated receiver, and the substantially improved signal enables high-spatial resolution images to be obtained (voxel size < 0.5 mm3). In patients being followed up after definitive surgery, in whom recurrence is suspected, MRI will be done using a standard phased array technique if the cervix is absent. In both instances, the MRI sequences will be standard and involve the use of T2-W and diffusion weighted sequences in 3 orthogonal planes. Contrast agents will not be administered. Intramuscular antiperistaltic agents (20 mg hyoscine butylbromide) are used routinely for pelvic imaging.
Histological analysis: Biopsies will be obtained from all patients with primary disease. This will be either a cone or LLETZ biopsy. In some cases with clearly visualized tumour due for radical hysterectomy, a punch biopsy may suffice for diagnosis.
In patients with suspected recurrence, a biopsy will be obtained if feasible and a visible mass is evident on imaging. In cases without a visible mass, or if biopsy is not feasible, vault cytology will be use as the gold standard. In the absence of adequate histology or cytology for validating the presence or absence of tumour, the patient will be withdrawn from the study.
Data Recording: Patient data will be recorded on case report forms. Patient data from case report forms will be recorded on a password protected study database. The MRI images will be placed onto the hospital picture archiving and communications system (PACS) and clinical reports will be available immediately to the referring clinicians.
Good Clinical Practice: The trial will be conducted in compliance with the protocol, standard operating procedures, policies, local R\&D management guidance, Good Clinical Practice including the Research Governance Framework 2005 including the current Human Tissue Act, Human Tissue (Quality and Safety for Human Application) Regulations, the Medical Devices Regulations and Ionising Radiation (Medical Exposures) Regulations.
- Conditions
- Cervical Cancer
- Being tested
- Tumour markers detection
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumour markers detectionDiagnostic test
Lab on a chip detection of tumour markers measured from vaginal/cervical cytology swab
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Tumour present on histology and MRI following biopsy/LLETZ Receives: Diagnostic Test: Tumour markers detection | |
| Group 2 | Tumour absent on MRI following biopsy/LLETZ Receives: Diagnostic Test: Tumour markers detection | |
| Group 3 | Tumour recurrence present at the vaginal vault on MRI Receives: Diagnostic Test: Tumour markers detection | |
| Group 4 | Tumour recurrence absent at the vaginal vault on MRI Receives: Diagnostic Test: Tumour markers detection | |
| Group 5 | Normal cervix at colposcopy Receives: Diagnostic Test: Tumour markers detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 months
Secondary outcomes (3)
Primary disease
To determine the sensitivity of tumour markers (HPV and cancer-specific gene overexpression) derived from lab-on-a-chip system in patients with primary cervical cancer (versus histology as the gold standard).
Measured: 20 months
Recurrent disease
To determine the sensitivity of tumour markers (HPV and cancer-specific gene overexpression) derived from lab-on-a-chip system in patients with recurrent cervical cancer (versus histology as the gold standard).
Measured: 20 months
Exploratory radiomic outcome
To determine association/correlation between radiomic features of tumour identified on endovaginal MRI with tumour markers (HPV and cancer-specific gene overexpression).
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study startApr 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, St George's University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380741
- Sponsor's protocol ID
- CCR4868
- Acronym
- MODULAR
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Diagnostics Using a Novel Lab-on-a-chip and MRI for Detecting Cervical Cancer
- ClinicalTrials.gov ID
- NCT03380741
- Acronym / sponsor ID
- MODULAR / CCR4868
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, St George's University Hospitals NHS Foundation Trust
- Study start
- Apr 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cervical cytology: This will be done prior to MRI at an out-patient visit or at the scan visit in all study subjects with cancer. IN those patients with a normal cervix at colposcopy, the sample will be taken as part of the colposcopy examination. The procedure will be identical to that used for cervical smear testing and involves the insertion of a speculum and taking a swab from the cervix and/ or vaginal vault for tumour marker assessment on lab-on-a-chip. Additionally, the sample will be examined conventionally to assess cytology.
MRI scan: For patients with primary disease, this will be done using an endovaginal technique. A ring design endovaginal coil will be inserted endovaginally around the cervix. It acts as a dedicated receiver, and the substantially improved signal enables high-spatial resolution images to be obtained (voxel size < 0.5 mm3). In patients being followed up after definitive surgery, in whom recurrence is suspected, MRI will be done using a standard phased array technique if the cervix is absent. In both instances, the MRI sequences will be standard and involve the use of T2-W and diffusion weighted sequences in 3 orthogonal planes. Contrast agents will not be administered. Intramuscular antiperistaltic agents (20 mg hyoscine butylbromide) are used routinely for pelvic imaging.
Histological analysis: Biopsies will be obtained from all patients with primary disease. This will be either a cone or LLETZ biopsy. In some cases with clearly visualized tumour due for radical hysterectomy, a punch biopsy may suffice for diagnosis.
In patients with suspected recurrence, a biopsy will be obtained if feasible and a visible mass is evident on imaging. In cases without a visible mass, or if biopsy is not feasible, vault cytology will be use as the gold standard. In the absence of adequate histology or cytology for validating the presence or absence of tumour, the patient will be withdrawn from the study.
Data Recording: Patient data will be recorded on case report forms. Patient data from case report forms will be recorded on a password protected study database. The MRI images will be placed onto the hospital picture archiving and communications system (PACS) and clinical reports will be available immediately to the referring clinicians.
Good Clinical Practice: The trial will be conducted in compliance with the protocol, standard operating procedures, policies, local R\&D management guidance, Good Clinical Practice including the Research Governance Framework 2005 including the current Human Tissue Act, Human Tissue (Quality and Safety for Human Application) Regulations, the Medical Devices Regulations and Ionising Radiation (Medical Exposures) Regulations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Diagnostic Test: Tumour markers detectionTumour present on histology and MRI following biopsy/LLETZ |
| Group 2 | – | Diagnostic Test: Tumour markers detectionTumour absent on MRI following biopsy/LLETZ |
| Group 3 | – | Diagnostic Test: Tumour markers detectionTumour recurrence present at the vaginal vault on MRI |
| Group 4 | – | Diagnostic Test: Tumour markers detectionTumour recurrence absent at the vaginal vault on MRI |
| Group 5 | – | Diagnostic Test: Tumour markers detectionNormal cervix at colposcopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with presumed early cervical cancer referred to the Gynaecological Oncology Units at The Royal Marsden Hospital and patients previously surgically treated for early cervical cancer currently undergoing follow up with suspected cancer recurrence will be invited to participate. Women attending St George's Hospital colposcopy clinic, who are judged to have a normal cervix on colposcopy examination will be invited to participate.
Key inclusion criteria (3 listed)
- • Patients with presumed early stage cervical cancer (squamous or adenocarcinoma on histology) being considered for curative surgery.
Key exclusion criteria (1 listed)
- Ferromagnetic metal implants, claustrophobia (MRI incompatibility). Neuroendocrine or unusual histological subtypes. Abnormal cervix seen at colposcopy examination (for Normal cervix cohort).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumour markers detectionLab on a chip detection of tumour markers measured from vaginal/cervical cytology swab | Diagnostic test | Group 2, Group 3, Group 4, Group 5, Group1 |
Primary outcome
Lab-on-a-chip agreement with PCR system
Time frame: 20 months
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.
3 secondary outcomes
Primary disease
Time frame: 20 months
Recurrent disease
Time frame: 20 months
Exploratory radiomic outcome
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Royal Marsden NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ben W Wormald, MBBS BSc (02086616101, Ben.wormald@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lab-on-a-chip agreement with PCR system (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2017.