Clinical trial: Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients (NCT03787056)

Eligibility criteria:
Inclusion Criteria:

        • Histologically and/or cytologically documented, newly diagnosed cancers for the following
        cohorts:

          -  Breast carcinomas

          -  Gastric carcinomas

          -  Renal carcinomas

          -  Prostate carcinomas

          -  Melanoma

          -  Lung carcinomas: NSCLC and SCLC

          -  Hepatocellular carcinomas

          -  Colorectal carcinomas

          -  Head and neck carcinomas

          -  Pancreatic carcinomas

          -  Ovarian adenocarcinomas

          -  Glioblastoma

          -  Endometrial adenocarcinomas

          -  Bladder carcinoma

          -  Superficial Oesophago-gastric carcinomas

          -  Diffuse Large B-cell Lymphomas

             • Patient older than 18 years.

             • Measured creatinine clearance > 30 mL/min or creatinine ≤ 1.5 x ULN

             • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN,
             unless liver metastases are present, in which case they must be ≤ 5 x ULN. For the
             hepatocellular carcinoma cohort, see details below

             • Serum bilirubin ≤ 1.5 x ULN. For the hepatocellular carcinoma cohort, see details
             below

             • 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…)

             • 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 …)

        The following tumor type specific inclusion criteria must be met in addition to the
        inclusion criteria listed above:

        Breast carcinomas

          -  Invasive breast ductal carcinoma, or

          -  Invasive breast lobular carcinoma • Curative intent treatment patient cohort:

          -  Planned to be treated with neo-adjuvant and/or adjuvant chemotherapy, surgery
             with/without anti-hormone treatment

        Gastric carcinomas

          -  Intestinal-type adenocarcinoma, or

          -  Diffuse cell type adenocarcinoma • Curative intent treatment patient cohort:

          -  Planned to be treated with neo-adjuvant and/or adjuvant chemotherapy, and surgery

        Renal carcinomas

          -  Any histology of renal cancer is accepted (non-clear cell renal cancer could be
             included)

             • Curative intent treatment patients cohort:

          -  Planned to be treated with partial or total nephrectomy

          -  A pathology proof of renal cell carcinoma is not necessary provided if patients
             present typical radiologic characteristics of renal cancer on imaging

        Prostate carcinomas

          -  Curative intent treatment patients cohort:

             o Localized prostate cancer with high risk features : StageT2b or T3 and/or Gleason >=
             4+3 and/or PSA >= 20 and/or N+

             o 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)

        Melanoma

          -  Stage I-IV melanoma, including ocular and mucosal melanoma

             • Curative intent treatment patients cohort:

          -  Planned to be treated with surgery with/without adjuvant treatment

        Lung carcinomas: NSCLC and SCLC

          -  Cytologically or histologically confirmed NSCLC (all subtypes) or SCLC. • Curative
             intent treatment patients cohort:

          -  NSCLC histology only

          -  Stage I-II according to 8th TNM classification

          -  Stage IIIA-B according to 8th TNM classification

          -  Histological/cytological diagnosis before curative surgery.

          -  Planned to be treated with radical treatment (surgery and/radiotherapy with/without
             concurrent chemotherapy), potentially associated with neo-adjuvant or adjuvant
             treatment • Non-curative intent patients cohort:

          -  NSCLC stage IV according to 8th TNM classification

          -  SCLC stage IV according to 8th TNM classification

        Hepatocellular carcinomas

          -  Aspartate aminotransferase / ASAT and Alanine aminotransferase / ALAT levels are
             accepted up to ≤ 5 x ULN

          -  Serum bilirubin ≤ 50 µM/L

          -  Absence or chronic hepatic encephalopathy, absence of refractory ascites, prothrombin
             rate ≥40% (or factor V ≥ 40% in case of antivitamin K therapy, albuminemia ≥ 25 g/L).

             • 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:

        o Lieberkühn adenocarcinoma associated with metastases planned to be treated with
        peri-operative chemotherapy +/- targeted agent and interval surgery

        Head and neck carcinomas

          -  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.

        Pancreatic carcinomas • Curative intent patients cohort:

        o Pancreas exocrine adenocarcinoma planned to be treated with initial surgery followed by
        adjuvant chemotherapy

        Ovarian adenocarcinomas • Curative intent patients cohort:

          -  High grade epithelial adenocarcinomas

          -  No indication of primary cytoreductive surgery due to disease extend

          -  Planned to be treated with neo-adjuvant chemotherapy followed by 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 (MVAC or dd-MVAC)

        Superficial Oesophago-gastric carcinomas

          -  Curative intent patients cohort:

               -  Superficial oesophago-gastric carcinomas of Stage T1 planned to be treated by
                  endoscopic surgery

        Diffuse Large B-Cell Lymphoma (DLBCL) • Curative intent patients cohort: o Patients planned
        to be treated with R-CHOP (Rituximab-Cyclophosphamide, Hydroxyadriamycine, Oncovin,
        Prednisone)

        Exclusion Criteria:

        Specific non-inclusion criteria for curative treatment strategy cancer patients:

          -  previous therapies for cancer for ≤ 5 years.

          -  history of previous cancers, except for adequately treated non-melanoma skin cancer,
             curatively treated in-situ cancer of the cervix, treated and with no evidence of
             disease for ≥ 5 years

        Specific non-inclusion criteria for non-curative treatment strategy cancer patients:

          -  history of previous cancers for ≤ 5 years, except for relapse of the current cancer
             after curative-intent treatment strategy

          -  Previous therapies for cancer in metastatic setting.

        Tumor type specific non-inclusion criteria:

        Breast carcinoma:

        • non adenocarcinoma tumor

        Gastric carcinoma:

        • non adenocarcinoma tumor

        Melanoma:

        • Melanoma in situ.

        Lung carcinoma:

          -  SCLC for curative-intent cohort

          -  Stage IV NSCLC with EGFR activating mutation, BRAF V600E mutation, ALK or ROS1 fusion.

        Hepatocellular carcinoma:

          -  Fibro-lamellar hepatocellular carcinoma.

          -  Mixed cholangio-carcinoma.

          -  Patients listed for liver transplantation.

        Colorectal carcinoma:

        • non adenocarcinoma tumor

        Head and neck carcinoma:

        • Carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell
        carcinoma of the skin or salivary gland, or non-squamous histology.

        Pancreatic carcinoma:

        • non adenocarcinoma tumor

        Ovarian adenocarcinoma:

          -  borderline tumors

          -  Germ cell tumors

          -  Carcinosarcoma, sex cord stromal tumors, clear-cells carcinomas

          -  Low-grade carcinomas

        Glioblastoma:

          -  Unresectable glioblastoma,

          -  Patient ineligible to post-operative temozolomide radiochemotherapy

        Endometrial adenocarcinoma:

        • Non adenocarcinoma tumor

        Superficial Oesophago-gastric carcinoma:

        • non adenocarcinoma tumor
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment