Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 410
- 试验地点
- 17
- 主要终点
- ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •o Intestinal-type adenocarcinoma, or
- •o 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:
- •o Localized prostate cancer with high risk features : StageT2b , T2c 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). 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:
- •o 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:
- •o NSCLC histology only
- •o Stage I-II according to 8th TNM classification
- •o Stage IIIA-B according to 8th TNM classification
- •o 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:
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排除标准
- 未提供
研究组 & 干预措施
Cancer patients
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.
干预措施: Blood draws (Other)
结局指标
主要结局
ROC curve AUC regarding diagnostic accuracy of progastrin levels at baseline in cancer patients compared to non-cancer controls
时间窗: At baseline
Progastrin concentration in plasma samples will be measured with an ELISA Kit (CancerREAD LAB) provided by ECS Progastrin.
次要结局
- The tumor size at cancer diagnosis(At baseline)
- Complete surgery(6 years)
- Longitudinal kinetic of progastrin values during treatments, assessed by modeled kinetic parameters of interest(6 years)
- Nycthemeral and weekly and post-operative progastrin variations(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(6 years)
- Determinants of progastrin serum values: renal function(6 years)
- Determinants of progastrin serum values: age(at the inclusion)
- Determinants of progastrin serum values: gender(at the inclusion)
- Overall survival(6 years)
- recurrence free survival(6 years)
- progression free survival(6 years)
- time to recurrence (for patients enrolled in curative intent cohorts).(6 years)
- time to progression (for patients enrolled in non-curative intent cohorts)(6 years)
- time to death (whenever it occurred)(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(at the baseline)