Ovarium Cancer Detection by TEP's and ctDNA
Early Detection of Ovarian Cancer and Treatment Response by Tumor Educated Platelets (TEP's) and Circulating Tumor DNA (ctDNA)
1 other identifier
observational
500
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
3 active sites
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
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJuly 17, 2019
July 1, 2019
4 years
July 9, 2019
July 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
accuracy of TEP's to determine the nature of an ovarian tumor
Prior to operation blood will be drawn of patients with an ovarian tumor. TEP's will be analysed as described before.
1 month
accuracy of ctDNA to determine the nature of an ovarian tumor
Prior to operation blood will be drawn of patients with an ovarian tumor. CtDNA will be analysed as described before.
1 month
accuracy of ctDNA to predict treatment response in ovarian cancer
Prior to debulking operation and pre and post chemotherapy ctDNA will be analysed in blood from patients with ovarian cancer as described before.
1 month
Study Arms (3)
ovarian tumor benign
all pathological proven benign ovarian tumors
ovarian tumor borderline
all pathological proven borderline ovarian tumors
ovarian tumor malignant
all pathological proven malignant ovarian tumors
Interventions
Eligibility Criteria
all women presenting with an ovarian tumor of unknown nature
You may qualify if:
- Suspicion of ovarian cancer.
You may not qualify if:
- Previous intraabdominal malignancies in the history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynaecologisch Oncologisch Centrum Zuidlead
- Leiden University Medical Centercollaborator
- The Netherlands Cancer Institutecollaborator
- Catharina Ziekenhuis Eindhovencollaborator
- Amsterdam UMC, location VUmccollaborator
Study Sites (3)
Catharina hospital
Eindhoven, North Brabant, 5623EJ, Netherlands
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX, Netherlands
Leiden University Medical Center
Leiden, North Holland, 2333 ZA, Netherlands
Biospecimen
Tumor educated platelets circulating tumor DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Wurdinger, PhD
Amsterdam UMC loc VUmc
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 17, 2019
Study Start
July 1, 2019
Primary Completion
July 1, 2023
Study Completion
December 1, 2023
Last Updated
July 17, 2019
Record last verified: 2019-07