Germ Cell Ovarian CancerSUMMERNCT06329323
SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours
An observational study of Germ Cell Ovarian Cancer and Germ Cell Tumor, run by Imperial College London.
Trial summary
The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology. The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Germ Cell Ovarian Cancer, Germ Cell Tumor, Germ Cell Cancer
- What is being tested?
- Blood test and Pathology specimen miRNA expression
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2024to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women aged over 16 with a diagnosis of a malignant ovarian germ cell tumour, benign ovarian germ cell tumour or no known gynaecological pathology may take part in this study.
Who may be able to join
- All patients with a new diagnosis of a malignant ovarian germ cell tumour.
- The control population will include all patients with a new diagnosis of a benign ovarian germ cell tumour or no known gynaecological pathology.
Who cannot join
- Previous or ongoing chemotherapy for MOGCT
- Previous surgery for MOGCT
- Pregnancy - this will be verbally communicated for those not having surgery or chemotherapy, for those having surgery or chemotherapy a urine pregnancy test should be negative and documented in the clinical notes.
- Fetal circulating DNA is known to be present in maternal blood and therefore pregnant women should not be included in this study
- Denial of informed consent
- Age <16 years
- History of any other cancer
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology.
The main question[s] it aims to answer are:
Read more
- To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)
- To understand the imaging profile of MOGCTs compared to that of BOGCTs
- To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease
- To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI
- To see if we can link the micro RNAs in tumour samples to those found in blood samples, and to find a plausible explanation for why these micro RNAs are raised (in terms of the tumour biology itself).aims
Participants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and/or remission and/or relapse. If they have surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their mass.
Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie. If a patient with a BOGCT requires surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their benign mass.
Read the detailed description
Case population (MOGCTs):
- Serum aFP (alpha fetoprotein), hCG (human chorionic gonadotrophin), LDH (lactate dehydrogenase) and Ca125 (cancer antigen 125) tumour markers measured at time of diagnosis
- Additional serum and plasma sample to be obtained at the same time as initial bloods
- Subsequent serum and plasma samples to be obtained as per study arms 1-3 based on cancer staging
- Tissue samples will be obtained at the time of surgery
Control population:
Participants acting as controls will be identified from those attending for TV-USS where either a benign teratoma or no pathology is identified (e.g. from a gynaecology clinic). A total of 26ml of blood will be taken. Serum aFP, hCG, LDH and Ca125 will be measured as per routine clinical practice in patients with a benign OGCT.
Patients in the control population (benign germ cell tumours or patients with no known gynaecological pathology) will have a single blood test for miRNA analysis.
If participants require an operation for the benign GCT, tissue samples will be obtained at the time of surgery.
miRNA analysis will be performed using NanoString for the discovery panel. Further targeted sequencing will be performed in the larger prospective study using specific miRNA panels. This may be done using NanoString or a custom MiRNA assay primer.
Endpoint The pilot will be completed after the final patient has completed 12 months of follow up. The pilot data analysis will take place at that point.
We anticipate that the study will end 12 months after the final participant has completed 24 months of follow up, which gives 12 months for analysis of the samples. The number of participants to take part will be based on a power calculation performed at the time of analysis of the pilot data.
DATA COLLECTION AND MANAGEMENT Patients will enter study arm 1-3 based on cancer staging, or will belong to the control group.
Each participant will be followed up for a maximum of 2 years after they receive their definitive treatment (surgery and/or (neo)adjuvant chemotherapy). We anticipate this will be a maximum of 30 months total time in the study.
An interim analysis of data will be performed at 12 months, with a view to:
- Identify key miRNAs for prospective validation
- Allow for appropriate power calculation of the prospective validation study
- Conditions
- Germ Cell Ovarian Cancer, Germ Cell Tumor, Germ Cell Cancer, Germ Cell Neoplasia, Ovary Cancer, Ovary Neoplasm
- Being tested
- Blood test, Pathology specimen miRNA expression
- Keywords
- Germ Cell Cancer, microRNA, miRNA, Ovarian Cancer
- Medical subject headings
- Ovarian Germ Cell Cancer, Neoplasms, Germ Cell and Embryonal, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Serum and plasma microRNA quantification
Pathology specimen miRNA expressionDiagnostic test
Pathology specimen mirNA expression - ALL MOGCT; OPTIONAL for BOGCT
| Study group | Role | What they receive |
|---|---|---|
| Cases- Malignant Ovarian Germ Cell Tumour - Arm 1 | Patients with a diagnosis of stage 1a MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks; 6 months; 12 months; 24 months post-operatively Receives: Diagnostic Test: Blood test; Diagnostic Test: Pathology specimen miRNA expression | |
| Cases - Malignant Ovarian Germ Cell Tumour - Arm 2 | Patients with a diagnosis of stage 1b/1c MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks; 6 months; 12 months; 24 months post-operatively OR post-final dose of adjuvant chemotherapy Receives: Diagnostic Test: Blood test; Diagnostic Test: Pathology specimen miRNA expression | |
| Cases - Malignant Ovarian Germ Cell Tumour - Arm 3 | Patients with a diagnosis of stage 2 or higher MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks post-neoadjuvant chemotherapy, then 4 weeks; 6 months; 12 months; 24 months post-operatively Receives: Diagnostic Test: Blood test; Diagnostic Test: Pathology specimen miRNA expression | |
| Controls - Benign Ovarian Germ Cell Tumour | Bloods taken at the time of diagnosis of BOGCT (single blood test) Receives: Diagnostic Test: Blood test; Diagnostic Test: Pathology specimen miRNA expression | |
| Controls - No Known Gynaecological Pathology | Single blood test Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in microRNA expression (plasma) between benign and malignant masses
Comparison of heatmaps based on mean expression of clusters across samples
Measured: 24 months
Difference in microRNA expression (serum) between benign and malignant masses
Comparison of heatmaps based on mean expression of clusters across samples
Measured: 24 months
microRNA expression (plasma)
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
Measured: 24 months
microRNA expression (serum)
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
Measured: 24 months
Secondary outcomes (8)
Quantitative measure of circulating miRNA before treatment
miRNA expression in plasma samples of women with a diagnosis of a MOGCT compared to those of women with BOGCTs using nCounter miRNA Expression panels
Measured: 24 months
Quantitative measure of circulating miRNA before treatment
miRNA expression in serum samples of women with a diagnosis of a MOGCT compared to those of women with BOGCTs using nCounter miRNA Expression panels
Measured: 24 months
Quantitative measure of circulating miRNA after treatment
miRNA expression in plasma samples of women with a diagnosis of a MOGCT compared to those of women with BOGCTs using nCounter miRNA Expression panels
Measured: 24 months
Quantitative measure of circulating miRNA after treatment
miRNA expression in serum samples of women with a diagnosis of a MOGCT compared to those of women with BOGCTs using nCounter miRNA Expression panels
Measured: 24 months
Performance of segmentation model on ultrasound images
Correlation between identification of region of interest (ROI) to examiner segmentation. Dice surface coefficient (DICE).
Measured: 24 months
Performance of segmentation model on MRI images
Correlation between identification of region of interest (ROI) to examiner segmentation. Dice surface coefficient (DICE)
Measured: 24 months
Performance of classification model on ultrasound images
Correlation between benign or malignant diagnosis by model vs ultrasound subjective assessment or histopathological diagnosis (area under the ROC curve (AUC), F1-score)
Measured: 24 months
Performance of classification model on MRI images
Correlation between benign or malignant diagnosis by model vs ultrasound subjective assessment or histopathological diagnosis (area under the ROC curve (AUC), F1-score)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start14 Apr 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Srdjan Saso, PhD MRCOG MRCS, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329323
- Sponsor's protocol ID
- 23CX8477
- Acronym
- SUMMER
- Status last verified
- Mar 2024
- First submitted
- 4 Dec 2023
- Last updated
- 26 Mar 2024
- Results posted
- 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 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SerUm and Plasma MicroRNAs in Malignant Ovarian gERm Cell Tumours
- ClinicalTrials.gov ID
- NCT06329323
- Acronym / sponsor ID
- SUMMER / 23CX8477
- Conditions
- Germ Cell Ovarian Cancer, Germ Cell Tumor, Germ Cell Cancer, Germ Cell Neoplasia, Ovary Cancer, Ovary Neoplasm
- Keywords
- Germ Cell Cancer, microRNA, miRNA, Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 14 Apr 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 25 Mar 2024 (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.
The goal of this observational case-control study is to learn about the circulating and tissue microRNA expression, imaging and radiomic profiles of malignant ovarian germ cell tumours (MOGCT) compared to patients with a benign OGCT and no ovarian pathology.
The main question[s] it aims to answer are:
- To understand the circulating miRNA expression of malignant ovarian germ cell tumours (MOGCTs) compared to those with benign ovarian germ cell tumours (BOGCTs)
- To understand the imaging profile of MOGCTs compared to that of BOGCTs
- To establish the relationship between serum and plasma miRNA expression in response to treatment and relapse of disease
- To discover if miRNA expression correlates with radiomic features of OGCTs on both ultrasound and MRI
- To see if we can link the micro RNAs in tumour samples to those found in blood samples, and to find a plausible explanation for why these micro RNAs are raised (in terms of the tumour biology itself).aims
Participants will have serial blood tests at different time points in their care to assess how circulating miRNA levels are affected by treatment and/or remission and/or relapse. If they have surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their mass.
Researchers will compare the circulating miRNA profile of patients with a benign ovarian germ cell tumour and no ovarian pathology to see where the differences lie. If a patient with a BOGCT requires surgery, a pathology sample will be taken from the main tumour specimen. Radiomic analysis will take place on existing ultrasound images of their benign mass.
Detailed description
Case population (MOGCTs):
- Serum aFP (alpha fetoprotein), hCG (human chorionic gonadotrophin), LDH (lactate dehydrogenase) and Ca125 (cancer antigen 125) tumour markers measured at time of diagnosis
- Additional serum and plasma sample to be obtained at the same time as initial bloods
- Subsequent serum and plasma samples to be obtained as per study arms 1-3 based on cancer staging
- Tissue samples will be obtained at the time of surgery
Control population:
Participants acting as controls will be identified from those attending for TV-USS where either a benign teratoma or no pathology is identified (e.g. from a gynaecology clinic). A total of 26ml of blood will be taken. Serum aFP, hCG, LDH and Ca125 will be measured as per routine clinical practice in patients with a benign OGCT.
Patients in the control population (benign germ cell tumours or patients with no known gynaecological pathology) will have a single blood test for miRNA analysis.
If participants require an operation for the benign GCT, tissue samples will be obtained at the time of surgery.
miRNA analysis will be performed using NanoString for the discovery panel. Further targeted sequencing will be performed in the larger prospective study using specific miRNA panels. This may be done using NanoString or a custom MiRNA assay primer.
Endpoint The pilot will be completed after the final patient has completed 12 months of follow up. The pilot data analysis will take place at that point.
We anticipate that the study will end 12 months after the final participant has completed 24 months of follow up, which gives 12 months for analysis of the samples. The number of participants to take part will be based on a power calculation performed at the time of analysis of the pilot data.
DATA COLLECTION AND MANAGEMENT Patients will enter study arm 1-3 based on cancer staging, or will belong to the control group.
Each participant will be followed up for a maximum of 2 years after they receive their definitive treatment (surgery and/or (neo)adjuvant chemotherapy). We anticipate this will be a maximum of 30 months total time in the study.
An interim analysis of data will be performed at 12 months, with a view to:
- Identify key miRNAs for prospective validation
- Allow for appropriate power calculation of the prospective validation study
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cases- Malignant Ovarian Germ Cell Tumour - Arm 1 | – | Diagnostic Test: Blood test, Diagnostic Test: Pathology specimen miRNA expressionPatients with a diagnosis of stage 1a MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks; 6 months; 12 months; 24 months post-operatively |
| Cases - Malignant Ovarian Germ Cell Tumour - Arm 2 | – | Diagnostic Test: Blood test, Diagnostic Test: Pathology specimen miRNA expressionPatients with a diagnosis of stage 1b/1c MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks; 6 months; 12 months; 24 months post-operatively OR post-final dose of adjuvant chemotherapy |
| Cases - Malignant Ovarian Germ Cell Tumour - Arm 3 | – | Diagnostic Test: Blood test, Diagnostic Test: Pathology specimen miRNA expressionPatients with a diagnosis of stage 2 or higher MOGCT. Bloods taken at the following time points: Day 0, then 4 weeks post-neoadjuvant chemotherapy, then 4 weeks; 6 months; 12 months; 24 months post-operatively |
| Controls - Benign Ovarian Germ Cell Tumour | – | Diagnostic Test: Blood test, Diagnostic Test: Pathology specimen miRNA expressionBloods taken at the time of diagnosis of BOGCT (single blood test) |
| Controls - No Known Gynaecological Pathology | – | Diagnostic Test: Blood testSingle blood test |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women aged over 16 with a diagnosis of a malignant ovarian germ cell tumour, benign ovarian germ cell tumour or no known gynaecological pathology may take part in this study.
Key inclusion criteria (2 listed)
- All patients with a new diagnosis of a malignant ovarian germ cell tumour.
- The control population will include all patients with a new diagnosis of a benign ovarian germ cell tumour or no known gynaecological pathology.
Key exclusion criteria (7 listed)
- Previous or ongoing chemotherapy for MOGCT
- Previous surgery for MOGCT
- Pregnancy - this will be verbally communicated for those not having surgery or chemotherapy, for those having surgery or chemotherapy a urine pregnancy test should be negative and documented in the clinical notes.
- Fetal circulating DNA is known to be present in maternal blood and therefore pregnant women should not be included in this study
- Denial of informed consent
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 |
|---|---|---|
| Blood testSerum and plasma microRNA quantification | Diagnostic test | Cases - Malignant Ovarian Germ Cell Tumour - Arm 2, Cases - Malignant Ovarian Germ Cell Tumour - Arm 3, Cases- Malignant Ovarian Germ Cell Tumour - Arm 1, Controls - Benign Ovarian Germ Cell Tumour, Controls - No Known Gynaecological Pathology |
| Pathology specimen miRNA expressionPathology specimen mirNA expression - ALL MOGCT; OPTIONAL for BOGCT | Diagnostic test | Cases - Malignant Ovarian Germ Cell Tumour - Arm 2, Cases - Malignant Ovarian Germ Cell Tumour - Arm 3, Cases- Malignant Ovarian Germ Cell Tumour - Arm 1, Controls - Benign Ovarian Germ Cell Tumour |
Primary outcome
Difference in microRNA expression (plasma) between benign and malignant masses
Time frame: 24 months
Comparison of heatmaps based on mean expression of clusters across samples
Difference in microRNA expression (serum) between benign and malignant masses
Time frame: 24 months
Comparison of heatmaps based on mean expression of clusters across samples
microRNA expression (plasma)
Time frame: 24 months
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
microRNA expression (serum)
Time frame: 24 months
Differential expression of microRNAs (assessed using a moderated t statistic and P values adjusted for multiple testing)
8 secondary outcomes
Quantitative measure of circulating miRNA before treatment
Time frame: 24 months
Quantitative measure of circulating miRNA before treatment
Time frame: 24 months
Quantitative measure of circulating miRNA after treatment
Time frame: 24 months
Quantitative measure of circulating miRNA after treatment
Time frame: 24 months
Performance of segmentation model on ultrasound images
Time frame: 24 months
Performance of segmentation model on MRI images
Time frame: 24 months
Performance of classification model on ultrasound images
Time frame: 24 months
Performance of classification model on MRI images
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- 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.
Srdjan Saso, PhD MRCOG MRCS principal investigator
Imperial College Healthcare NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Germ Cell Ovarian Cancer and Germ Cell Tumor, run by Imperial College London.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 26 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina C Cooper, MBBS BSc (02033513150, nina.cooper3@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in microRNA expression (plasma) between benign and malignant masses (time frame: 24 months). The study lists 4 primary outcomes in all. 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 26 Mar 2024.