NCT04022863

Ovarium Cancer Detection by TEP's and ctDNA

Status unknown Last updated 17 July 2019

What this trial tests

trial testing TEP in Ovarian Neoplasms in 500 participants. Status unknown.

Timeline

1 July 2019

Primary endpoint
1 July 2023

1 December 2023

Quick facts

Lead sponsor	Gynaecologisch Oncologisch Centrum Zuid
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 July 2019
Primary completion	1 July 2023
Estimated completion	1 December 2023
Sites	3 locations across Netherlands

Drugs / interventions tested

• TEP — full drug profile →
• ctDNA

Conditions studied

• Ovarian Neoplasms — all drugs for Ovarian Neoplasms →

Sponsor

Gynaecologisch Oncologisch Centrum Zuid — full company profile →

Who can join

Adults 18 to 90, female only, with Ovarian Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potential clinical utility of liquid biopsies in ovarian cancer.
   Zhu JW, Charkhchi P, Akbari MR. · · 2022 · cited 110× · PMID 35545786 · DOI 10.1186/s12943-022-01588-8
2. Future Screening Prospects for Ovarian Cancer.
   Žilovič D, Čiurlienė R, Sabaliauskaitė R, Jarmalaitė S. · · 2021 · cited 30× · PMID 34359740 · DOI 10.3390/cancers13153840
3. Molecular Management of High-Grade Serous Ovarian Carcinoma.
   Punzón-Jiménez P, Lago V, Domingo S, Simón C, et al · · 2022 · cited 28× · PMID 36430255 · DOI 10.3390/ijms232213777
4. High-Grade Serous Ovarian Cancer-A Risk Factor Puzzle and Screening Fugitive.
   Wilczyński J, Paradowska E, Wilczyński M. · · 2024 · cited 9× · PMID 38275400 · DOI 10.3390/biomedicines12010229
5. Advances and challenges in the use of liquid biopsy in gynaecological oncology.
   Zhang Y, Tian L. · · 2024 · cited 8× · PMID 39492906 · DOI 10.1016/j.heliyon.2024.e39148