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出境医 / 临床实验 / Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment (EMIT)
Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment (EMIT)
Study Description
Brief Summary:
- To establish whether circulating tumour DNA is detectable in the plasma of patients with platinum refractory/resistant Germ Cell Tumours
-
If ctDNA is detectable, perform exploratory analyses to:
- Describe the molecular aberrations in plasma from metastatic GCTs with platinum refractory/resistant disease
- Describe aberrations detected in sequential detected in sequential samples form the same individual patient and evaluate whether there are hyposthesis-generating changes that temporarily associate with clinical resistance.
| Condition or disease |
|---|
| Testicular Germ Cell Tumor |
Detailed Description:
This project will study the plasma of patients who have metastatic GCTs with platinum refractory/resistant disease in order to establish if ctDNA is detectable and then analyse the molecular aberrations. Archival diagnostic tissue will be recalled (this is the tissue used to make the initial diagnosis of testicular cancer). Excess tissue acquired from clinically mandated prospective biopsies will be stored and plasma which has been collected at a maximum of 15 time-points per year will be analysed. Clinical data will be accessed to make clinically meaningful associations with plasma and tissue molecular aberrations.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 18 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment |
| Estimated Study Start Date : | August 2019 |
| Estimated Primary Completion Date : | March 2020 |
| Estimated Study Completion Date : | August 2021 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Circulating DNA in plasma is measurable [ Time Frame: 1 year ]Measurement of plasma of patients with platinum refractory/resistant germ cell tumours
- Exploratory analysis of circulating DNA [ Time Frame: 1 year ]
- describe the molecular aberrations in plasma from metastatic germ cell tumours with platinum resistant/refractory disease
- Describe aberrations detected in sequential samples from the same indivivdual patient and evaluate whether there are hypothesis-generating changes that temporally associate with clinical resistance
Biospecimen Retention: Samples With DNA
Whole blood samples have been collected and stored in Royal Marsden Biobank. Archived tumour samples may also be used.
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients will have consented to the collection and storage of blood samples and archival tissue at the RMH bio-bank. Testicular cancer management is focused in a single multidisciplinary clinic (Sutton Friday AM) and is the centre for follow up of these patients. We propose to initially analyseclinical material from 18 patients who have attended this clinic. To meet our primary objective, patient samples will be selected based on the burden of metastatic tumour in the patient at the time of the blood sample. Samples will be selected from patients at the latest available time-point in their disease process where the disease burden was at its highest.
The minimum sample requirement for our primary and secondary objectives is a blood sample taken during at least one timepoint. However if there are an excess of patients with bloods samples collected when metastatic disease burden is at its highest, patient samples will be preferentially selected if they have sequential samples.
Criteria
Inclusion Criteria:
- Patients with histologically confirmed metastatic GCT refractory/resistant to platinum treatment
- Patients who have signed the 'Tissues for Research' consent form at the Royal Marsden Hospital and have blood samples stored in the RMH Biobank.
- Patients with no prior or current non-testicular invasive malignancy within the last 3 years, other than non-melanoma skin cancer or NCCN low risk prostate cancer (pT1 or pT2a Gleason ≤ 6, PSA ≤ 10 and ≤ 1cc total volume)
Exclusion Criteria:
- n/a
Contacts and Locations
Contacts
| Contact: Reid | 0208 6426011 ext 4319 | alison.reid@rmh.nhs.uk | |
| Contact: Jenni Parmar | 0208 6113070 | jenni.parmar@rmh.nhs.uk |
Locations
| United Kingdom | |
| Royal Marsden NHS Trust | Recruiting |
| London Borough of Sutton, Surrey, United Kingdom, SM2 5PT | |
| Contact: Gandolfi 0208 8642661 ann.gandolfi@rmh.nhs.uk | |
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
University College London (UCL) Cancer Institute
Investigators
| Principal Investigator: | Alison Reid | Royal Marsden NHS Foundation Trust |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 29, 2019 | ||||||||
| First Posted Date | June 10, 2019 | ||||||||
| Last Update Posted Date | June 10, 2019 | ||||||||
| Estimated Study Start Date | August 2019 | ||||||||
| Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment | ||||||||
| Official Title | Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment | ||||||||
| Brief Summary |
|
||||||||
| Detailed Description | This project will study the plasma of patients who have metastatic GCTs with platinum refractory/resistant disease in order to establish if ctDNA is detectable and then analyse the molecular aberrations. Archival diagnostic tissue will be recalled (this is the tissue used to make the initial diagnosis of testicular cancer). Excess tissue acquired from clinically mandated prospective biopsies will be stored and plasma which has been collected at a maximum of 15 time-points per year will be analysed. Clinical data will be accessed to make clinically meaningful associations with plasma and tissue molecular aberrations. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Whole blood samples have been collected and stored in Royal Marsden Biobank. Archived tumour samples may also be used.
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population |
Patients will have consented to the collection and storage of blood samples and archival tissue at the RMH bio-bank. Testicular cancer management is focused in a single multidisciplinary clinic (Sutton Friday AM) and is the centre for follow up of these patients. We propose to initially analyseclinical material from 18 patients who have attended this clinic. To meet our primary objective, patient samples will be selected based on the burden of metastatic tumour in the patient at the time of the blood sample. Samples will be selected from patients at the latest available time-point in their disease process where the disease burden was at its highest. The minimum sample requirement for our primary and secondary objectives is a blood sample taken during at least one timepoint. However if there are an excess of patients with bloods samples collected when metastatic disease burden is at its highest, patient samples will be preferentially selected if they have sequential samples. |
||||||||
| Condition | Testicular Germ Cell Tumor | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
18 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 2021 | ||||||||
| Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United Kingdom | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03980587 | ||||||||
| Other Study ID Numbers | CCR4911 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Royal Marsden NHS Foundation Trust | ||||||||
| Study Sponsor | Royal Marsden NHS Foundation Trust | ||||||||
| Collaborators | University College London (UCL) Cancer Institute | ||||||||
| Investigators |
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| PRS Account | Royal Marsden NHS Foundation Trust | ||||||||
| Verification Date | March 2019 | ||||||||
