An observational study in Psychological Distress, Pancreatic Cancer and Colorectal Cancer, sponsored by Xuanwu Hospital, Beijing. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Xuanwu Hospital, Beijing · Observational
This prospective observational cohort study aims to investigate the association between psychological distress and clinical outcomes in patients with digestive system cancers, including pancreatic, gastric, and colorectal cancers.
Approximately 100 adult patients who are scheduled to receive first-line systemic anticancer therapy will be enrolled at Xuanwu Hospital, Capital Medical University. Psychological distress will be assessed using the Distress Thermometer (DT), Hospital Anxiety and Depression Scale (HADS), and 12-item General Health Questionnaire (GHQ-12).
Participants will undergo baseline assessments and follow-up evaluations every three months for up to three years. Clinical information, psychological distress scores, laboratory findings, imaging results, and quality-of-life data will be collected.
The primary outcome is progression-free survival (PFS). Secondary outcomes include overall survival (OS), objective response rate (ORR), and quality of life. The study will evaluate whether psychological distress is associated with cancer prognosis after adjusting for potential confounding factors, including cancer stage, treatment regimen, and nutritional status.
As an observational study, no experimental treatment will be assigned, and all participants will receive standard anticancer treatment according to routine clinical practice.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of approximately 100 adult patients with pathologically confirmed pancreatic, gastric, or colorectal cancer who are scheduled to receive first-line systemic anticancer therapy at the Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. Eligible patients will be consecutively enrolled according to the predefined inclusion and exclusion criteria. Psychological distress will be assessed at baseline and during follow-up to investigate its association with clinical outcomes, including progression-free survival and overall survival.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from study enrollment to the first radiologically confirmed disease progression, as assessed by the investigator according to RECIST version 1.1, or death from any cause, whichever occurs first. PFS will be compared between patients with high and low levels of psychological distress.
Time frame: From enrollment to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 3 years.
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2026, 19 months after the start.
Of 318 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 182. This study's planned 19 months is below that.
Counting every sponsor, half of 352 studies reached it within 60 months; a quarter within 34 and three quarters within 182.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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