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Digestive Peritoneal CarcinomatosisBIG-RENAPENCT02823860

Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies

A study testing Collection of biospecimens and Quality of Life (QoL) assessment in people with Digestive Peritoneal Carcinomatosis, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To access to good quality biological samples is a prerequisite for high level translational research. The BIG-RENAPE study has been established by the French hyperthermic intraperitoneal chemotherapy centers involved in the management of peritoneal surface malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Digestive Peritoneal Carcinomatosis
What is being tested?
Collection of biospecimens and Quality of Life (QoL) assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,186 participants
Where
1 siteFrance
Study dates
12 Feb 2016to 13 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men / women aged over 18 years
  • Patients with cancer management and care for peritoneal carcinomatosis of digestive origin
  • Patients had histologic/radiologic confirmation of peritoneal disease
  • Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research;
  • Ability of participants to give their informed consent

Who cannot join

  • Minor patient
  • Adult unable to consent
  • Patient refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

Other trials in France

About this study

To access to good quality biological samples is a prerequisite for high level translational research. The BIG-RENAPE study has been established by the French hyperthermic intraperitoneal chemotherapy centers involved in the management of peritoneal surface malignancies.

The main BIG-RENAPE study aim is to create a large multicentric and prospective repository for biological and tissue samples, which will provide a source of materials for a wide array of health related research studies - BIG-RENAPE Biobank-based research: i) validating known and promising biomarkers; ii) identifying new predictive and prognostic factors; iii) evaluating the impact of current health care strategies; iv) standardizing diagnostic and therapeutic management through guidelines; v) developing new drugs.

The BIG-RENAPE Biobank is certified according to NFS 96-900 as a service of processing, storage and transfer of high quality biological (plasma, serum, buffy coat) and tissue (formalin-fixed-paraffin-embedded) samples. Biospecimens are collected at each stage of diagnostic and therapeutic care. The patient and his derivates are anonymized and registered in a national web database reporting disease status, treatments, surgical procedures, pathological diagnosis, quality of life's assessment and long term follow-up. All participants have given their informed consent before any sample. The BIG-RENAPE study was approved by the local Ethical Committee, based on the assessed compliance to French regulatory rules.

Being tested
Collection of biospecimens and Quality of Life (QoL) assessment
Keywords
Peritoneal carcinomatosis, Biobanking, Biospecimen research, Prospective clinical database, Tissue banking, Quality of Life, various histological subtypes
Medical subject headings
Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of biospecimens and Quality of Life (QoL) assessmentOther

    Serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE). Biospecimens are collected at various stages of diagnostic and therapeutic care.All patients fill out questionnaires of Health related quality of life (QLQ-C30 + QLQ-CR29/STO22, Hospital Anxiety and Depression scale - HAD) and social-demographic survey (Medical Outcome Studies - Social Support Survey- MOS-SSS).

Study groups in NCT02823860
Study groupRoleWhat they receive
Biospecimens and Quality of Life (QoL)OtherOnly if patient's consent is obtained, biospecimens, including tumor and/or peripheral blood are collected.
Receives: Other: Collection of biospecimens and Quality of Life (QoL) assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resistance to oncological treatments

    Resistance to treatments (systemic and intraperitoneal chemotherapy, surgical procedures and targeted therapies) in patients treated for digestive peritoneal carcinomatosis is defined as a change of therapeutic strategy decided during a multidisciplinary meeting.

    The biological and tumoral factors related to resistance of oncological treatments will be identified from the laboratory tests results and histological analyses.

    Biospecimens types: serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE).

    Biospecimens are collected at various stages of diagnostic and therapeutic care

    Measured: During the 3-year follow-up

  2. Presence of biological and tumoral factors related to resistance to oncological treatments

    The biological and tumoral factors related to resistance of oncological treatments will be identified from the laboratory tests results and histological analyses.

    Biospecimens types: serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE).

    Biospecimens are collected at various stages of diagnostic and therapeutic care The biological and tumoral factors related to resistance of oncological treatments will be identified from the laboratory tests results and histological analyses.

    Biospecimens types: serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE).

    Biospecimens are collected at various stages of diagnostic and therapeutic care

    Measured: During the 3-year follow-up

Secondary outcomes (8)

  1. Presence of clinical factors related to resistance to oncological treatments.

    Demographic, pathological, clinical information are recorded electronically on a secured Web application and linked to biospecimens identification.

    Measured: During the 3-year follow-up

  2. Incidence of recurrence and survival

    Impact of therapeutics strategies on the incidence of recurrence and survival

    Measured: at 3 years

  3. social characteristics of patients by MOS-SSS test, according to their therapeutic car modalities

    The Medical Outcomes Study Social Support Survey (MOS-SSS) is used as a self-administered measure of functional social support for chronically ill persons. The 19 items cover four domains (emotional/informational support, tangible support, positive social interaction, and affection).

    Measured: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months

  4. quality of life measured by questionnaires (composite measure composed of QLQ-C30, QLQ-CR29 and QLQ-STO22 questionnaires), according to treatment strategies

    The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.

    The QLQ-CR29 was administered with the QLQ-C30 core questionnaire. It is meant for use among colorectal cancer patients varying in disease stage and treatment modality. The module comprises 29 questions assessing the colorectal cancer-specific symptom scales (disease symptoms, side effects of treatment) and functional scales (body image, sexuality, and future perspective).

    The QLQ-STO22 was administered with the QLQ-C30 core questionnaire. The QLQ-STO22 module contains 22 items regarding dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss.

    Measured: at baseline (day 0), 1 month post baseline (M1) 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months

  5. Intensity of pain perceived by the patient measured by VAS scale

    The patient's perception intensity of pain is measured with a Visual Analogue Scale (VAS).

    Measured: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months

  6. Presence of epidemiological and demographic determinants of delayed access to treatment induction or surgical procedure

    Epidemiological and demographic factors will be assessed from the prospective and clinical database.

    Measured: During the 3-year follow-up

  7. Presence of prognostic and predictive biomarkers related to resistance to oncological treatments .

    The prognostic and predictive biomarkers related to resistance of oncological treatments will be identified from the biological tumoral and clinical data.

    Measured: During the 3-year follow-up

  8. behavioral characteristics of patients by HADS Scale, according to their therapeutic car modalities

    The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, is used to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.

    Measured: at baseline (day 0), 1 month post baseline (M1), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study start12 Feb 2016
  3. Primary completion13 Oct 2022
  4. Study completion13 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02823860
Sponsor's protocol ID
69HCL14_0345
Acronym
BIG-RENAPE
Status last verified
Dec 2025
First submitted
30 May 2016
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No

Publications

  • Peron J, Mercier F, Tuech JJ, Younan R, Sideris L, Gelli M, Dumont F, Le Roy B, Sgarbura O, Lo Dico R, Bibeau F, Glehen O, Passot G; on behalf BIG-RENAPE working groups. The location of the primary colon cancer has no impact on outcomes in patients undergoing cytoreductive surgery for peritoneal metastasis. Surgery. 2019 Feb;165(2):476-484. doi: 10.1016/j.surg.2018.07.027. Epub 2018 Sep 7.

    PubMed 30197280

  • Bonnefoy I, Mohamed F, Bonnot PE, Benzerdjeb N, Isaac S, Cotte E, Glehen O, Passot G. Risk of Omental Metastases in Patients Undergoing Cytoreductive Surgery for Colorectal Peritoneal Metastases. Dis Colon Rectum. 2020 Sep;63(9):1251-1256. doi: 10.1097/DCR.0000000000001670.

    PubMed 32618618

Questions about this trial

What is this clinical trial studying?

A study testing Collection of biospecimens and Quality of Life (QoL) assessment in people with Digestive Peritoneal Carcinomatosis, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resistance to oncological treatments (time frame: During the 3-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02823860, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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