---
title: Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
nct_id: NCT03302884
overall_status: UNKNOWN
phase: NA
sponsor: Institut Paoli-Calmettes
study_type: INTERVENTIONAL
primary_condition: Ovarian Carcinoma
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03302884.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03302884"
ct_last_update_post_date: 2019-09-26
last_seen_at: "2026-05-12T07:29:13.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma

**NCT ID:** [NCT03302884](https://clinicaltrials.gov/study/NCT03302884)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** Institut Paoli-Calmettes
- **Collaborators:** AstraZeneca
- **Conditions:** Ovarian Carcinoma
- **Start Date:** 2018-10-10
- **Completion Date:** 2023-10-30
- **CT.gov Last Update:** 2019-09-26

## Brief Summary

Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

## Detailed Description

The main objective is to explore the capacity of ctDNA to be an early marker of ovarian carcinoma recurrence after front-line treatments, i.e. to show significant modifications before clinical diagnosis of disease relapse.

Prospective multicentre open-label study

During visits in the frame of management of the disease, blood samples will be collected at diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the following 2 years, and every year during the remainin time of follow-up. Tumor samples will be collected at surgery or through a biopsy.

Patients will then have a standard care follow-up for a period of 5 years.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy.
2. Indication of preoperative and/or adjuvant chemotherapy.
3. Age ≥ 18 years old.
4. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
5. Signed written informed consent prior to any screening procedures being performed

Non inclusion Criteria:

1. Contraindication to surgical assessment.
2. Pathological diagnosis of mucinous carcinoma.
3. History of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer).
4. Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol.
5. Patient in urgency situation, adult under legal protection, or unable to give his consent.

Exclusion Criteria after histological exam:

Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.
```

## Arms

- **Biological sampling in ovarian carcinoma** (EXPERIMENTAL) — Blood and tumor samples

## Interventions

- **biological sampling** (OTHER) — Tumor and blood samples

## Primary Outcomes

- **Prognostic value of ctDNA increase for predicting a subsequent clinical, radiological (RECIST v1.1) or biological (CA-125 according to GCIG criteria) diagnosis of disease relapse.** _(time frame: at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years)_ — Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir

## Locations (3)

- Centre Jean Perrin, Clermont-Ferrand, France — _RECRUITING_
- Centre Oscar Lambret, Lille, France — _RECRUITING_
- Institut Du Cancer de Montpellier, Montpellier, France — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre jean perrin|clermont-ferrand||france` — added _(2026-05-12)_
- `locations.centre oscar lambret|lille||france` — added _(2026-05-12)_
- `locations.institut du cancer de montpellier|montpellier||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03302884.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03302884*  
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