Condition or disease | Intervention/treatment |
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Ovarian Neoplasms | Diagnostic Test: TEP Diagnostic Test: ctDNA |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Month |
Official Title: | Early Detection of Ovarian Cancer and Treatment Response by Tumor Educated Platelets (TEP's) and Circulating Tumor DNA (ctDNA) |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | July 1, 2023 |
Estimated Study Completion Date : | December 1, 2023 |
Group/Cohort | Intervention/treatment |
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ovarian tumor benign
all pathological proven benign ovarian tumors
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Diagnostic Test: TEP
Tumor Educated Platelets
Diagnostic Test: ctDNA circulating tumor DNA
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ovarian tumor borderline
all pathological proven borderline ovarian tumors
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Diagnostic Test: TEP
Tumor Educated Platelets
Diagnostic Test: ctDNA circulating tumor DNA
|
ovarian tumor malignant
all pathological proven malignant ovarian tumors
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Diagnostic Test: TEP
Tumor Educated Platelets
Diagnostic Test: ctDNA circulating tumor DNA
|
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | women with ovarian tumors |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jurgen M Piek, MD, PhD | +31(0)40239 9111 | jurgen.piek@catharinaziekenhuis.nl | |
Contact: Volkher Scharnhorst, MD, PhD | +31(0)40239 9111 | volkher.scharnhorst@catharinaziekenhuis.nl |
Netherlands | |
Catharina hospital | Recruiting |
Eindhoven, Brabant, Netherlands, 5623EJ | |
Contact: Jurgen M Piek, MD. PhD. +31(0)40 239 9111 jurgen.piek@catharinaziekenhuis.nl | |
Netherlands Cancer Institute | Recruiting |
Amsterdam, Noord Holland, Netherlands, 1066 CX | |
Contact: Christianne Lok, MD; PhD | |
Leiden University Medical Center | Recruiting |
Leiden, Noord Holland, Netherlands, 2333 ZA | |
Contact: Cor D de Kroon, MD, PhD |
Principal Investigator: | Thomas Wurdinger, PhD | Amsterdam UMC loc VUmc |
Tracking Information | |||||||||
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First Submitted Date | July 9, 2019 | ||||||||
First Posted Date | July 17, 2019 | ||||||||
Last Update Posted Date | July 17, 2019 | ||||||||
Actual Study Start Date | July 1, 2019 | ||||||||
Estimated Primary Completion Date | July 1, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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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 | Ovarium Cancer Detection by TEP's and ctDNA | ||||||||
Official Title | Early Detection of Ovarian Cancer and Treatment Response by Tumor Educated Platelets (TEP's) and Circulating Tumor DNA (ctDNA) | ||||||||
Brief Summary | Rationale: Cancer is primarily diagnosed by clinical presentation, imaging and pathological analysis of tissue biopsies, increasingly supported by molecular diagnostics tests. However, late diagnosis and misdiagnosis due to limitations of tissue biopsy acquisition remains a major problem. Therefore, a general blood test to pinpoint cancer early and adequately can be considered the 'Holy Grail', because diagnosis in an earlier stage significantly improves the chance of cure from cancer. Several blood-based sources are currently being evaluated as liquid biopsies, including circulating tumor (ct) DNA and circulating tumor cells, but none of these have been implemented for primary (multiclass) cancer diagnostics. Protein tumor markers have been used for decades in diagnosis and monitoring of treatment response in different cancers. Tumor-educated platelets (TEPs) can function as potential blood-based source for (early) cancer diagnostics. Blood platelets are implicated in hemostasis and wound healing. Platelets have recently emerged as central players and immediate responders in the systemic and local responses to tumor growth. Confrontation of platelets by tumor cells via transfer of tumor-associated molecules ('education') results in the sequestration of these molecules (derived from both tumor and its micro-environment), causing a distinct platelet messenger Ribonucleic acid (mRNA) profile. We have previously shown that platelets acquire glioblastoma and prostate cancer mRNA biomarkers and that glioblastoma TEP mRNA profiles harbour diagnostic potential. Furthermore, circulating tumor desoxyrubonucleic acid (ctDNA) has recently been implicated as biomarker for therapy effectiveness and survival. Objective: develop and evaluate the potential of combination of tumor markers, TEPs and ctDNA as liquid biomarkers for (early) ovarium cancer diagnostics and as markers for therapy response and survival. Study design: investigator-initiated, longitudinal, observational study. Study population: patients suspected of having ovarium cancer and are therefore planned for surgery. Main study parameters/endpoints: The difference in biomarker profile from benign ovarium lesions versus cancerous lesions. Nature and extent of the burden and risks associated with participation, benefit and group relatedness. There is no extra burden/risk for the patients in this study. Three extra vials of blood. | ||||||||
Detailed Description | Cancer is primarily diagnosed by clinical presentation, radiology, biochemical tests and pathological analysis of tumor tissue, increasingly supported by molecular diagnostic tests. Molecular profiling of tumor tissue samples has emerged as a potential cancer classifying method. In order to overcome limitations of tissue acquisition the use of blood-based liquid biopsies has been suggested. Several blood-based sources are currently being evaluated as liquid biopsies, including plasma DNA and circulating tumor cells. So far, implementation of liquid biopsies for early detection of cancer has been hampered by non-specificity of these sources to pinpoint the nature of the primary tumor. It has been reported that tumor-educated platelets (TEPs) may enable blood-based cancer diagnostics. Platelets are circulating anucleated cell fragments that originate from megakaryocytes in bone marrow, and are traditionally known for their role in hemostasis and initiation of wound healing. More recently, platelets have emerged as central players in the systemic and local responses to tumor growth. Confrontation of platelets with tumor cells via transfer of tumor-associated biomolecules ('education') is an emerging concept and results in the sequestration of such biomolecules. Moreover, external stimuli, such as activation of platelet surface receptors and lipopolysaccharide-mediated platelet activation induce specific splicing of pre-mRNAs in circulating platelets. Platelets may also undergo queue-specific splice events in response to signals released by cancer cells and the tumor microenvironment -such as stromal and immune cells-. The combination of specific splice events in response to external signals and the capacity of platelets to directly ingest (spliced) circulating mRNA can provide TEPs with a highly dynamic mRNA repertoire, with potential applicability to cancer diagnostics. Additionally, the value of other biomarkers that can be derived from a liquid biopsy will be tested in this study. In addition, recently a hallmark paper has shown that combinations of protein tumor markers and ctDNA analysis could discriminate persons with different types of cancer from healthy controls with on average 70% sensitivity (at 99% specificity). In the case of ovarium cancer the sensitivity was 98%. Obvious advantages of liquid biopsy compared to tissue biopsy is the easy accessibility of the material to be obtained and the fact that tumor derived material in blood may cover the cancer heterogeneity where a tissue biopsy is limited to the alterations in the tumor punctured. Therefore, this study investigates the clinical value of longitudinal assessment of liquid biopsy-derived information in diagnosis and monitoring of treatment response in patients suspected of ovarian cancer. | ||||||||
Study Type | Observational [Patient Registry] | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 1 Month | ||||||||
Biospecimen | Retention: Samples With DNA Description:
Tumor educated platelets circulating tumor DNA
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Sampling Method | Non-Probability Sample | ||||||||
Study Population | all women presenting with an ovarian tumor of unknown nature | ||||||||
Condition | Ovarian Neoplasms | ||||||||
Intervention |
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Study Groups/Cohorts |
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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 |
500 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 1, 2023 | ||||||||
Estimated Primary Completion Date | July 1, 2023 (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 | 18 Years to 90 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Netherlands | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04022863 | ||||||||
Other Study ID Numbers | NL68037.100.18 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Jurgen M.J. Piek, Gynaecologisch Oncologisch Centrum Zuid | ||||||||
Study Sponsor | Gynaecologisch Oncologisch Centrum Zuid | ||||||||
Collaborators |
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Investigators |
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PRS Account | Gynaecologisch Oncologisch Centrum Zuid | ||||||||
Verification Date | July 2019 |