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Completed

NCT Number: NCT02595281

HE4 as a Relapse Biomarker in Ovarian Cancers

HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.

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Key information

Conditions

Ovarian Carcinoma Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

LONGO Raphaelle, Metz, CHU Metz Thionville, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ovarian adenocarcinoma stage IIIa, IIIb or IV pleural, cytologically or histologically proven
  • Patient scheduled to undergo neoadjuvant chemotherapy based on platinum followed by surgery and adjuvant chemotherapy
  • Age ≥ 18 years .
  • Performance status ECOG > or = 2
  • Adequate haemoglobin rate ≥ 10 g/dL
  • Ability to provide written informed consent
  • Patient's legal capacity to consent to study participation

Exclusion criteria

  • Any previous treatment with platinum for ovarian carcinoma
  • Patient with visceral metastases
  • Contraindication for blood test
  • Contraindication for surgery
  • Contraindication for bevacizumab treatment

Treatment and study plan

Experimental Arm

Other

Serum samples are collected:

  • at each neoadjuvant chemotherapy cycle
  • before surgery
  • at each adjuvant chemotherapy cycle
  • at each injection of bevacizumab as maintenance therapy
  • stop at the progression or after 24 months post chemotherapy

Primary outcomes

  1. To evaluate the predictive and prognostic value of HE4 marker

    Time frame: 24 months

    Serum concentration of HE4 (pMol) will be analysed at each visit

Secondary outcomes

  1. Compare the evolution of HE4 and CA-125 serum concentration

    Time frame: 24 months

    Serum concentration of HE4 and CA-125 (pMol) will be analysed and compared at the time of diagnosis, at each neoadjuvant chemotherapy cycle, before the surgery, and at each chemotherapy cycle

  2. Evaluate the progression-free survival at 18 months

    Time frame: 24 months

    HE4 and CA125 will be compared with the rate of progression-free survival

  3. Evaluate the quality of surgery

    Time frame: 24 months

    HE4 and CA125 will be compared with completeness of cancer resection score (CCR score).

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

Determination of the Interest of HE4 as a Relapse Biomarker in Ovarian Cancers Stages IIIb, IIIc and IV After Neo-adjuvant Chemotherapy and Surgery.

Acronym: PRONOV4IR

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2015
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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