Ovarium Cancer Detection by TEP's and ctDNA

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.

Conditions

• Ovarian Neoplasms

Interventions

DIAGNOSTIC_TEST

TEP

Tumor Educated Platelets

DIAGNOSTIC_TEST

ctDNA

circulating tumor DNA

Sponsors & Collaborators

• Leiden University Medical Center

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Gynaecologisch Oncologisch Centrum Zuid

  lead OTHER

Principal Investigators

• Thomas Wurdinger, PhD · Amsterdam UMC loc VUmc

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2023-07-01

Completion

2023-12-01

Countries

• Netherlands

Study Locations