Skip to content

ASCITES study

A precision medicine approach to predict chemotherapy sensitivity in ascites of ovarian cancer patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20712
Enrollment
100
Registered
2017-12-22
Start date
2017-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In advanced stage ovarian cancer patients 20-30% of the patients do not respond to primary (chemotherapy) treatment. 20-30% van de patiënten met gevorderd ovariumcarcinoom heeft geen goede respons op de 1e keus chemotherapie die wordt gegeven.

Interventions

Ascites drainage One extra blood tube Both are standard of care (the blood tube is extra)

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Histologically confirmed ovarian, tubal or extra-ovarian peritoneal cancer - Availability of ascites - Availability of blood cells to determine gene status in normal (i.e., non-tumor) cells - Ascites collected before start of chemotherapy - No prior chemotherapy - No concomitant cancer - Age 18 years and above - Ability to undergo first line treatment (debulking surgery and chemotherapy) - Treatment to commence within 6 weeks - Written informed consent

Exclusion criteria

Exclusion criteria: - Previous chemotherapy - Previous or concurrent malignant disease except basal cell carcinoma

Design outcomes

Primary

MeasureTime frame
Development and validation of a precision medicine approach based on the analysis of drug sensitivity markers in ascites of ovarian cancer patients.

Secondary

MeasureTime frame
1. To compare clinical response on chemotherapy with the histopathological response seen in the tumor after neoadjuvant chemotherapy. To develop a new (histopathologic) parameter of response that is applicable in daily practice. 2. To study the immunological response in ascites of EOC patients before and after chemotherapy. To come to a better understanding of the role of the immune system in the development of ovarian cancer.

Contacts

Public ContactJudith den Ouden

Radboudumc

Judith.e.denouden@radboudumc.nl06-55287802

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)