UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000002384 |
| Receipt No. | R000002910 |
| Scientific Title | Metabolome analysis of cachexia and its circadian rhythms in patients with advanced pancreatic cancer. |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2019/12/25 (Ver. 11) |
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| Basic information | ||
| Public title | Metabolome analysis of cachexia and its circadian rhythms in patients with advanced pancreatic cancer. | |
| Acronym | Metabolome analysis in advanced pancreatic cancer patients with cachexia. | |
| Scientific Title | Metabolome analysis of cachexia and its circadian rhythms in patients with advanced pancreatic cancer. | |
| Scientific Title:Acronym | Metabolome analysis in advanced pancreatic cancer patients with cachexia. | |
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| Condition | ||
| Condition | advanced pancreatic cancer | |
| Classification by specialty |
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| Classification by malignancy | Malignancy | |
| Genomic information | YES | |
| Objectives | |
| Narrative objectives1 | To explore the metabolites on cachexia in patients with advanced pancreatic cancer by metabolom analysis. |
| Basic objectives2 | Others |
| Basic objectives -Others | Biomarker |
| Trial characteristics_1 | Exploratory |
| Trial characteristics_2 | Explanatory |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | The metabolites on cachexia by metabolom analysis |
| Key secondary outcomes | The circadian rhythms of the metabolites on cachexia |
| Base | |
| Study type | Observational |
| Study design | |
| Basic design | |
| Randomization | |
| Randomization unit | |
| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
| No. of arms | |
| Purpose of intervention | |
| Type of intervention | |
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| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | 1. histologically or cytologically diagnosed adenocarcinoma or adenosquamous carcinoma
2. locally advanced or metastatic pancreatic cancer 3. A) patients without cachexia B) patients with cachexia 4. age of 20 years or older 5. adequate baseline organ function 6. patients provided written informed consent |
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| Key exclusion criteria | 1. resectable pancreatic cancer
2. pancreatic neuroendcrine carcinoma 3. chemotherapy within 1 week 4. surgery within 1 month 5. deffinitive radiotherapy within 1 month 6. palliative radiotherapy within 2 weeks 7. uncontroled infection 8. uncontroled diabetic mellitus 9. condition that required corticosteroid |
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| Target sample size | 20 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Kobe University Graduate School of Medicine | ||||||
| Division name | Medical Oncology | ||||||
| Zip code | 50-0017 | ||||||
| Address | 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan | ||||||
| TEL | 0783825111 | ||||||
| hminami@ncc.go.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Kobe University Graduate School of Medicine | ||||||
| Division name | Medical Oncology | ||||||
| Zip code | 50-0017 | ||||||
| Address | 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan | ||||||
| TEL | 0783825111 | ||||||
| Homepage URL | |||||||
| fu_ji_@yahoo.co.jp | |||||||
| Sponsor | |
| Institute | Medical Oncology, Kobe University Graduate School of Medicine
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| Institute | |
| Department | |
| Funding Source | |
| Organization | Medical Oncology, Kobe University Graduate School of Medicine |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
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| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Kobe university |
| Address | 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan |
| Tel | 078-382-5111 |
| rinri@med.kobe-u.ac.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | None |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113259 | ||||||
| Number of participants that the trial has enrolled | 21 | ||||||
| Results | Levels of paraxanthine remained markedly lower in the cohort with cachexia at all measurement points. Besides, median IL-6 and TNF levels appeared higher and leptin concentration appeared lower in the cachexia group, albeit without statistical significance. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Cancer cachexia is a multifactorial syndrome characterized by progressive loss of weight and muscle atrophy. Using metabolomics, we investigated serum markers and their intra-day variation in advanced pancreatic cancer patients with cachexia. |
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| Participant flow | Twenty-one patients were enrolled in total. |
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| Adverse events | Nothing paticular |
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| Outcome measures | Blood samples collected at 6:30 AM, 11:30 AM, 4:30 PM, and 9:30 PM were analyzed using metabolomics, and serum levels of IL-6, TNF, and leptin were measured and compared between the two groups |
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| Progress | |||||||
| Recruitment status | Main results already published | ||||||
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| Other | |
| Other related information | Case controle sampling
Prospective study |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002910 |
