CancerONCOPRONCT03787056
Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients
A study testing Blood draws in people with Cancer and Breast Cancer, run by Hospices Civils de Lyon at 17 sites in France.
Trial summary
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast Cancer, Gastric Cancer
- What is being tested?
- Blood draws
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 17 sitesFrance
- Study dates
- 4 Dec 2018to 4 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Histologically and/or cytologically documented (documentation obtained before or after diagnostic surgical procedure when clinical suspicion is strong), cancers for the following cohorts:
- Breast carcinomas
- Gastric carcinomas
- Renal carcinomas
- Prostate carcinomas
- Lung carcinomas: NSCLC and SCLC
- Hepatocellular carcinomas
- Colorectal carcinomas
- Head and neck carcinomas
- Thyroid cancer
- Pancreatic carcinomas
- Ovarian adenocarcinomas
- Glioblastoma
- Endometrial adenocarcinomas
- Bladder carcinoma
- Superficial Oesophago-gastric carcinomas
- Diffuse Large B-cell Lymphomas
- Patient older than 18 years.
- Patients who gave its written informed consent to participate to the study
- Patients affiliated to a social insurance regime
Specific inclusion criteria for curative treatment strategy cancer patients:
- Indication of a treatment strategy with curative intent (surgery; radiotherapy; chemotherapy; hormonotherapy; targeted agents…)
- Patient naïve of anticancer treatments for the considered cancer
- A prior anti-cancer treatment is allowed if this treatment was performed with curative intent, and if it did not include systemic chemotherapy, and if a complete remission ≥ 6 months was observed in between the end of treatment and relapse. Previous local treatments for superficial lesions are allowed without any time restriction (for example among others, intravesical treatment for superficial bladder cancer lesions).
Specific inclusion criteria for non-curative treatment strategy cancer patients:
- Indication of a treatment strategy with no curative intent (radiotherapy; chemotherapy; hormonotherapy; immunotherapy; targeted agents, non-curative surgery, …)
- Patient naïve of anticancer treatments in non-curative setting (except for metastatic hormone-sensitive prostate cancer, see specific inclusion criteria).
The following tumor type specific inclusion criteria must be met in addition to the inclusion criteria listed above:
Breast carcinomas
- All cohorts:
- Invasive breast ductal carcinoma, or
- Invasive breast lobular carcinoma
- Curative intent treatment patient cohort:
- Planned to be treated with surgery, with/without neo-adjuvant and/or adjuvant chemotherapy and/or anti-hormone treatment
Gastric carcinomas
- All cohorts:
- Intestinal-type adenocarcinoma, or
- Diffuse cell type adenocarcinoma
- Curative intent treatment patient cohort:
- Planned to be treated with surgery with/without neo-adjuvant treatment, with/without adjuvant treatment
Renal carcinomas • All cohorts:
- Any histology of renal cancer is accepted (non-clear cell renal cancer could be included)
- A pathology proof of renal cell carcinoma is not necessarily provided if patients present typical radiologic characteristics of renal cancer on imaging
- Curative intent treatment patients cohort:
- Planned to be treated with partial or total nephrectomy
Prostate carcinomas
- Curative intent treatment patients cohort:
- Localized prostate cancer with high risk features : StageT2b , T2c or T3 and/or Gleason >= 4+3 and/or PSA >= 20 and/or N+
- Planned to be treated with radical prostatectomy or radiotherapy (potentially associated with androgen deprivation therapy). Brachytherapy and/or focused ultrasounds are not allowed.
- Non-curative intent treatment patients cohort:
- Patients with metastatic castration resistant prostate cancer (mCRPC) defined by validated criteria of EAU, planned to be treated with doceteaxel or cabazitaxel or second generation hormone (i.e. abiraterone or enzalutamide). Patients have to be naïve of treatment for the castration resistant mCRPC. Patients that previously received docetaxel or a 1st or 2nd generation hormonotherapy for their hormone-sensitive prostate cancer in metastatic setting can be included.
Lung carcinomas treated by immunotherapy :
- Non-curative intent patients cohort:
- NSCLC stage IV according to 8th TNM classification planned to be treated with immunotherapy, with/ without chemotherapy
Lung carcinomas excluding those treated with immunotherapy:
- Curative intent treatment patients cohort:
- NSCLC histology only
- Stage I-II according to 8th TNM classification
- Stage IIIA-B according to 8th TNM classification
- Planned to be treated with radical treatment (surgery or radiotherapy with/without concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant treatment
- Non-curative intent patients cohort:
- NSCLC or SCLC stage IV according to 8th TNM classification planned to be treated with a first line of chemotherapy, with/without associated treatments except immunotherapy (radiotherapy, targeted therapies…). Immunotherapy can be administrated for the subsequent lines of treatment.
Hepatocellular carcinomas A pathology proof of HCC is not necessarily provided if patients present typical radiologic characteristics of hepatocellular carcinoma on imaging
- Absence or chronic hepatic encephalopathy, absence of refractory ascites
- Curative intent treatment patients cohort:
- Indication of a treatment strategy with curative intent, except liver transplantation: surgical resection, monopolar radiofrequency ablation for HCC (1 to 3 nodules ≤3 cm) or multibipolar radiofrequency if nodule ≤4 cm).
- Non-curative intent patients cohort:
- Indication of a treatment strategy with no curative intent: transarterial intra-hepatic chemoembolization, targeted therapies (tyrosine kinase inhibitors or monoclonal antibodies) or immune therapy.
Colorectal carcinomas
- Curative intent treatment patients cohort:
- Lieberkühn adenocarcinoma associated with metastases planned to be treated with peri-operative chemotherapy +/- targeted agent and interval surgery
Head and neck carcinomas
- All cohorts
- Head and neck squamous cell carcinoma from oral cavity, oropharynx, hypopharynx, larynx
- Curative intent treatment patients cohort:
- Planned to be treated with a radical treatment (surgery and/or radiotherapy potentially associated with concurrent chemotherapy) with/without neo-adjuvant/adjuvant chemotherapy.
- Non-curative intent treatment patients cohort:
- De novo metastatic or metastatic/loco-regional relapse planned to be treated with chemotherapy and/or immunotherapy
Thyroid cancer • Curative intent patient cohort o Thyroid carcinoma differentiated, poorly differentiated, papillary, vesicular, Hurthle Cell o For which a iodine treatment is indicated (Iodine treatment will be discussed after surgery. In the case the histological result does not confirm a high risk thyroid cancer, patient will be withdrawn from the study. In the same way, if a iodine treatment is not recommended after surgery, patient will be withdrawn from the study. In both cases, patient will be replaced).
Pancreatic carcinomas
- Curative intent patients cohort:
- Pancreas exocrine adenocarcinoma planned to be treated with initial surgery with/without neo-adjuvant chemotherapy and with/without adjuvant chemotherapy or radiotherapy
Ovarian adenocarcinomas • Non/uncertain curative intent patients cohort:
- 1st platinum-sensitive relapse
- High or low grade epithelial adenocarcinomas or carcinosarcoma
- Planned to be treated with chemotherapy and/or PARP inhibitors based treatment, +/- interval debulking surgery
Glioblastoma • Curative intent patients cohort:
- Planned to be treated with surgical resection, followed by adjuvant temozolomide and radiotherapy
Endometrial adenocarcinomas
- Non-curative intent patients cohort:
- Type 1 (endometrioid or mucinous) or type 2 endometrial (serous, clear cell, undifferentiated carcinoma and carcinosarcoma) cancers
- Planned to be treated with non-curative systemic treatment for metastatic or advanced disease
Bladder carcinoma
- Transitional cell carcinoma • Curative intent treatment patients:
- Patients with localized muscle invasive bladder cancer (>=PT2)
- Planned to be treated with neo-adjuvant cisplatin based chemotherapy, or immunotherapy or a combination of chemotherapy and immunotherapy
Superficial Oesophago-gastric cancer • Curative intent patients cohort:
- Superficial oesophago-gastric carcinomas (adenocarcinomas or epidermoid carcinomas) of Stage T1 planned to be treated by endoscopic surgery
Diffuse Large B-Cell Lymphoma (DLBCL)
- Curative intent patients cohort:
- Patients planned to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin, Prednisone)
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 17 recruiting
- Recruiting
Service de NEURO-ONCOLOGIE du Groupement Hospitalier EST
Bron
Francois DUCRAY, MD, francois.ducray@chu-lyon.fr
Francois DUCRAY, MD
- Recruiting
Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'hôpital de la Croix-Rousse
Lyon
Marielle GUILLET, MD, marielle.guillet@chu-lyon.fr
Marielle GUILLET, MD
- Recruiting
Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'Hôpital E. Herriot
Lyon
Thomas WALTER, MD, thomas.walter@chu-lyon.fr
Thomas WALTER, MD
- Recruiting
Service d'Oto-Rhino-Laryngologie de l'Hôpital de la Croix-Rousse
Lyon
Amandine BRUYAS, MD, amandine.bruyas@chu-lyon.fr
Amandine BRUYAS, MD
- Recruiting
Service d'Urologie de l'Hôpital E. Herriot
Lyon
Lionel BADET, MD, lionel.badet@chu-lyon.fr
Lionel BADET, MD
- Recruiting
Service de Gynécologie de l'hôpital de la Croix-Rousse
Lyon
Marion CORTET, MD, marion.cortet@chu-lyon.fr
Marion CORTET, MD
- Recruiting
Service de Gynécologie du Groupement Hospitalier Est
Lyon
Christophe SAJOUS, MD, christophe.sajous@chu-lyon.fr
Christophe SAJOUS, MD
- Recruiting
Service de Pneumologie de l'hôpital de la Croix-Rousse
Lyon
Gilles DEVOUASSOUX, MD, gilles.devouassoux@chu-lyon.fr
Gilles DEVOUASSOUX, MD
- Recruiting
Service de Pneumologie du Groupement Hospitalier Est
Lyon
Michael DURUISSEAUX, MD, michael.duruisseaux@chu-lyon.fr
Michael DURUISSEAUX, MD
- Recruiting
Service d'Hématologie de l'Hôpital Lyon Sud
Pierre-Bénite
Lionel KARLIN, MD, lionel.karlin@chu-lyon.fr
Lionel KARLIN, MD
- Recruiting
Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE du Centre Hospitalier Lyon Sud
Pierre-Bénite
Marion CHAUVENET, MD, marion.chauvenet@chu-lyon.fr
Marion CHAUVENET, MD
- Recruiting
Service d'Oncologie médicale du Centre hospitalier Lyon Sud
Pierre-Bénite
Benoit YOU, MD, benoit.you@chu-lyon.fr
Benoit YOU, MD
- Recruiting
Service d'Urologie de l'hôpital Lyon Sud
Pierre-Bénite
Philippe PAPAREL, MD, philippe.paparel@chu-lyon.fr
Philippe PAPAREL, MD
- Recruiting
Service de Chirurgie de l'hôpital Lyon Sud
Pierre-Bénite
Olivier GLEHEN, MD, olivier.glehen@chu-lyon.fr
Olivier GLEHEN, MD
- Recruiting
Service de Dermatologie de l'hôpital Lyon Sud
Pierre-Bénite
Stephane DALLE, MD, stephane.dalle@chu-lyon.fr
Stephane DALLE, MD
- Recruiting
Service de Gynécologie de l'hôpital Lyon Sud
Pierre-Bénite
Pierre Adrien BOLZE, MD, pierre-adrien.bolze@chu-lyon.fr
Pierre Adrien BOLZE, MD
- Recruiting
Service de Pneumologie de l'Hôpital Lyon Sud
Pierre-Bénite
Sebastien COURAUD, MD, sebastien.couraud@chu-lyon.fr
Sebastien COURAUD, MD
About this study
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal.
In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.
Read more
Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation.
Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.
- Conditions
- Cancer, Breast Cancer, Gastric Cancer, Renal Cancer, Prostate Cancer, Melanoma
- Being tested
- Blood draws
- Keywords
- dd, TUMOR MARKER, PROGASTRIN
- Medical subject headings
- Neoplasms, Breast Neoplasms, Stomach Neoplasms, Kidney Neoplasms, Prostatic Neoplasms, Melanoma, Lung Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawsOther
Blood draws are realized at each steps of patient disease management. The volume of each blood drawn is 25 mL for progastrin measurements and 5 mL for the dosage of the other tumor markers. The frequency depend to the cancer and treatment administered :
- Baseline at diagnosis : Local radical treatment : within 24h before surgery, within 24h after surgery and at the post-surgery follow up visit
- Chemotherapy treatment : every 3 or 4 weeks
- Radiotherapy : start day and at the end of radiation ("end of treatment" visit)
- Palliative systemic treatment (only palliative cohorts) : every 3 to 12 weeks. Follow until the third progression or change of treatment line, or alternatively up to 5 years after inclusion
- In case of PD or TOX
- Follow up: at each visit scheduled (every 3 months) for the first 2 years, then every 6 months for 3 years
- Relapse : withdrawn from the study and last progastrin measurement. Patient could be enrolled in the non-curative intent cohort
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Other | 420 patients affected by different types of cancer and treated in a curative or a palliative intent. In total 17 cohorts will be open, including: breast cancer, head and neck carcinomas, renal cell carcinoma, prostate carcinoma, lung carcinoma, hepatocellular carcinoma, colorectal carcinoma, thyroid cancer, pancreatic adenocarcinoma, ovarian adenocarcinoma, glioblastoma, endometrial adenocarcinoma, bladder carcinoma, oesophago-gastric carcinoma, B-cell lymphoma, gastric carcinomas. Patients enrolled in curative intent treatment cohorts will never have been previously treated for their cancer. Patients enrolled in non-curative intent treatment cohorts will have never been treated for their metastatic cancers previously, or have developed advanced/metastatic diseases as relapses of localized cancers previously treated with curative intent therapeutic strategies. Other cohort will be open (stability cohorts) : nychtemer cohort and post-operative kinetic cohort. Receives: Other: Blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
Progastrin concentration in plasma samples will be measured with an ELISA Kit (CancerREAD LAB) provided by ECS Progastrin.
Measured: At baseline
Secondary outcomes (15)
Longitudinal kinetic of progastrin values during treatments, assessed by modeled kinetic parameters of interest
A nonlinear mixed effect model will be used to model the progastrin measurements done during treatments and follow-up of patients.The effect of each event (chemotherapy, surgery…) on the progastrin value and in the inter-individual variability of production and/or elimination rates of progastrin will be analyzed. Progastrin will be measured by ELISA, and the values will be expressed in pM.
Measures will be done depending on the treatment received. Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients.
Measured: 6 years
Nycthemeral and weekly and post-operative progastrin variations
24 patients will be selected, upon their agreement and serum high levels, to enter in nychtemer (12 patients) or weekly (12 patients) cohorts. For the Nychtemer cohort, progastrin will be assayed at d1 at 8:00 am; 11:00 am; 2:00 pm; 5:00 pm; 8:00 pm and at d2 at 8:00 For the weekly cohort, progastrin will be assayed Day 1; Day 8; Day 15 and +/- Day 22; ideally on the same hour times. Progastrin will be measured by ELISA, and the values will be expressed in pM.
Measured: every 3 hours within 24 hours for the Nycthemeral cohort, and every week for 2 or 3 weeks for the weekly cohort
Determinants of progastrin serum values: hepatic function
A nonlinear mixed effect model will be used to correlate individual values of progastrin (expressed in pM) with individual characteristic on the patient (hepatic function, as measured by the concentration of AST, ALT and bilirubin).
Measures will be done Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients
Measured: 6 years
Determinants of progastrin serum values: renal function
A nonlinear mixed effect model will be used to correlate individual values of progastrin (expressed in pM) with individual characteristic on the patient (renal function, as measured by creatinin concentration and creatinin clearance).
Measures will be done Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients
Measured: 6 years
Determinants of progastrin serum values: age
A nonlinear mixed effect model will be used to correlate the individual characteristics of the patient (age and gender) with progastrin concentration at the inclusion.
Measured: at the inclusion
Determinants of progastrin serum values: gender
A nonlinear mixed effect model will be used to correlate genders with progastrin concentrations at the inclusion.
Measured: at the inclusion
Overall survival
The relationships between the progastrin kinetics during and after treatment and overall survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment.
Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
Measured: 6 years
recurrence free survival
The relationships between the progastrin kinetics during and after treatment and recurrence free survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment.
Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
Measured: 6 years
progression free survival
The relationships between the progastrin kinetics during and after treatment and progression free survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment.
Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.
Measured: 6 years
The tumor size at cancer diagnosis
The size of the tumor will be correlated to progastrin concentration at the time of cancer diagnosis
Measured: At baseline
Complete surgery
The ability of progastrin kinetics during the neoadjuvant period to predict the outcome of the surgery (complete or not) will be analyzed by a ROC curve. If applicable.
Measured: 6 years
time to recurrence (for patients enrolled in curative intent cohorts).
The ability of the progastrin kinetics to predict recurrence free survival (curative cohorts), will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up.
Measured: 6 years
time to progression (for patients enrolled in non-curative intent cohorts)
The ability of the progastrin kinetics to predict progression-free survival (non-curative cohorts) will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up
Measured: 6 years
time to death (whenever it occurred)
The ability of the progastrin kinetics to predict time to death will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up
Measured: 6 years
Comparison of the initial values and of the kinetics of other serum tumor markers (CA15-3, CA 19-9, CA125, CEA, PSA, AFP) with those of progastrin
The ROC AUC will be compared between classical markers and the prograstrin. Logistic regression will be used to combine the classical marker(s) and the progastrin in order to estimate the diagnostic value of the marker combination.
progastrin, CA15-3, CA19-9, CA125, CEA, PSA and AFP concentration will be measured on blood sample taken at the inclusion.
Measured: at the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start4 Dec 2018
- Primary completion4 Jan 2028 (estimated)
- Study completion4 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit YOU, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787056
- Sponsor's protocol ID
- 69HCL18_0369
- Acronym
- ONCOPRO
- Status last verified
- Jul 2021
- First submitted
- 26 Oct 2018
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
You B, Couraud S, Ceruse P, Badet L, Paparel P, Durand A, Guillet M, Merle P, Lescuyer G, Philip CA, Ducray F, Pioche M, Karlin L, Lifante JC, Glehen O, Bolze PA, Chauvenet M, Langlois-Jacques C, Subtil F, Piecyk M, Carrot A, Joubert D, Prieur A, Vire B, Calattini S, Payen L. Diagnostic value of the wnt target and cancer-associated blood biomarker hPG80: ONCOPRO case-control prospective study. Biomark Res. 2025 Jul 1;13(1):91. doi: 10.1186/s40364-025-00793-z.
PubMed 40598473
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients
- ClinicalTrials.gov ID
- NCT03787056
- Acronym / sponsor ID
- ONCOPRO / 69HCL18_0369
- Conditions
- Cancer, Breast Cancer, Gastric Cancer, Renal Cancer, Prostate Cancer, Melanoma
- Keywords
- dd, TUMOR MARKER, PROGASTRIN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 4 Jan 2028 (estimated)
- Study completion
- 4 Jan 2028 (estimated)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal.
In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.
Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation.
Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | Other | Other: Blood draws420 patients affected by different types of cancer and treated in a curative or a palliative intent. In total 17 cohorts will be open, including: breast cancer, head and neck carcinomas, renal cell carcinoma, prostate carcinoma, lung carcinoma, hepatocellular carcinoma, colorectal carcinoma, thyroid cancer, pancreatic adenocarcinoma, ovarian adenocarcinoma, glioblastoma, endometrial adenocarcinoma, bladder carcinoma, oesophago-gastric carcinoma, B-cell lymphoma, gastric carcinomas. Patients enrolled in curative intent treatment cohorts will never have been previously treated for their cancer. Patients enrolled in non-curative intent treatment cohorts will have never been treated for their metastatic cancers previously, or have developed advanced/metastatic diseases as relapses of localized cancers previously treated with curative intent therapeutic strategies. Other cohort will be open (stability cohorts) : nychtemer cohort and post-operative kinetic cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawsBlood draws are realized at each steps of patient disease management. The volume of each blood drawn is 25 mL for progastrin measurements and 5 mL for the dosage of the other tumor markers. The frequency depend to the cancer and treatment administered : * Baseline at diagnosis : Local radical treatment : within 24h before surgery, within 24h after surgery and at the post-surgery follow up visit * Chemotherapy treatment : every 3 or 4 weeks * Radiotherapy : start day and at the end of radiation ("end of treatment" visit) * Palliative systemic treatment (only palliative cohorts) : every 3 to 12 weeks. Follow until the third progression or change of treatment line, or alternatively up to 5 years after inclusion * In case of PD or TOX * Follow up: at each visit scheduled (every 3 months) for the first 2 years, then every 6 months for 3 years * Relapse : withdrawn from the study and last progastrin measurement. Patient could be enrolled in the non-curative intent cohort | Other | Cancer patients |
Primary outcome
ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
Time frame: At baseline
Progastrin concentration in plasma samples will be measured with an ELISA Kit (CancerREAD LAB) provided by ECS Progastrin.
15 secondary outcomes
Longitudinal kinetic of progastrin values during treatments, assessed by modeled kinetic parameters of interest
Time frame: 6 years
Nycthemeral and weekly and post-operative progastrin variations
Time frame: every 3 hours within 24 hours for the Nycthemeral cohort, and every week for 2 or 3 weeks for the weekly cohort
Determinants of progastrin serum values: hepatic function
Time frame: 6 years
Determinants of progastrin serum values: renal function
Time frame: 6 years
Determinants of progastrin serum values: age
Time frame: at the inclusion
Determinants of progastrin serum values: gender
Time frame: at the inclusion
Overall survival
Time frame: 6 years
recurrence free survival
Time frame: 6 years
progression free survival
Time frame: 6 years
The tumor size at cancer diagnosis
Time frame: At baseline
Complete surgery
Time frame: 6 years
time to recurrence (for patients enrolled in curative intent cohorts).
Time frame: 6 years
time to progression (for patients enrolled in non-curative intent cohorts)
Time frame: 6 years
time to death (whenever it occurred)
Time frame: 6 years
Comparison of the initial values and of the kinetics of other serum tumor markers (CA15-3, CA 19-9, CA125, CEA, PSA, AFP) with those of progastrin
Time frame: at the baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 40598473You B, Couraud S, Ceruse P, Badet L, Paparel P, Durand A, Guillet M, Merle P, Lescuyer G, Philip CA, Ducray F, Pioche M, Karlin L, Lifante JC, Glehen O, Bolze PA, Chauvenet M, Langlois-Jacques C, Subtil F, Piecyk M, Carrot A, Joubert D, Prieur A, Vire B, Calattini S, Payen L. Diagnostic value of the wnt target and cancer-associated blood biomarker hPG80: ONCOPRO case-control prospective study. Biomark Res. 2025 Jul 1;13(1):91. doi: 10.1186/s40364-025-00793-z.
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Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benoit YOU, MD principal investigator
Hospices Civils de Lyon
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draws in people with Cancer and Breast Cancer, run by Hospices Civils de Lyon at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit YOU, MD (04 78 86 43 53 ext. +33, benoit.you@hu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls (time frame: At baseline). 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 NCT03787056, which also lists 1 linked publication.
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 16 Jul 2021.