Clinical Study on the Expression of PHGDH and Its Prognostic Value in Colorectal Cancer Patients Receiving Immunotherapy

Study links PHGDH gene to immunotherapy success in colorectal cancer

NCT: NCT07508046 · Status: COMPLETED · Phase: N/A · Sponsor: West China Hospital · Started: 2025-11-01 · Est. Completion: 2026-01-01

Plain English Summary

Clinical Study on the Expression of PHGDH and Its Prognostic Value in Colorectal Cancer Patients Receiving Immunotherapy is a Not Applicable clinical trial sponsored by West China Hospital studying Colo-rectal Cancer. This study looks at a gene called PHGDH and how its levels in tumors might predict how well patients with colorectal cancer respond to immunotherapy. It's for patients who have already been treated with immunotherapy for colorectal cancer. Researchers will examine stored tumor tissue and medical records; no new treatments are given. This research helps understand if PHGDH can be a marker to guide future treatment decisions. The trial aims to enroll 100 participants.

Official Summary

This study aims to evaluate the expression characteristics of PHGDH in tumor tissues based on the clinical data and pathological tissue samples of colorectal cancer patients who have previously received immunotherapy, and to analyze its correlation with patients' clinical features, immunotherapy efficacy, and survival prognosis, providing a basis for clarifying the clinical relevance of PHGDH.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have confirmed colorectal cancer and have received at least one dose of immunotherapy. Your tumor tissue must be available from before treatment for testing. You cannot join if you have other active cancers (except certain skin or cervix cancers) or if your tumor tissue is not available. You also cannot join if you stopped immunotherapy early or if your medical records are incomplete. This trial is studying Colo-rectal Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how often immunotherapy works to shrink tumors, helping to understand if PHGDH levels are linked to better or worse treatment responses. The specific primary outcome measures are: Objective Response Rate (ORR) (Assessed at 3 months after initiation of immunotherapy.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it seeks to identify a biomarker that could help doctors choose the most effective immunotherapy for colorectal cancer patients, addressing a gap in personalized treatment. This research targets Colo-rectal Cancer, where improved treatment options are needed.

Investor Insight

This observational study provides insights into potential biomarkers for immunotherapy response in a significant cancer type, which could inform future diagnostic tool development and treatment strate

Is This Trial Right for Me?

Ask your doctor if your tumor tissue is available and if you meet the study criteria. Participation involves allowing researchers to review your medical records and analyze your stored tumor tissue. There is no new treatment involved; your care will continue as planned by your doctor. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

1. Patients with histologically confirmed colorectal adenocarcinoma.
2. Initiated treatment with immune checkpoint inhibitors (at least one cycle) between June 1, 2018 and December 31, 2025.
3. Availability of pre-treatment archival tumor tissue (FFPE block or slides) for PHGDH immunohistochemistry testing.
4. Have evaluable baseline radiographic images (CT or MRI) prior to immunotherapy.
5. Sufficient medical records for survival follow-up data extraction.

Exclusion Criteria:

1. Unavailability of adequate tumor tissue for PHGDH expression analysis.
2. Permanently discontinued immunotherapy prior to the first scheduled radiological response assessment.
3. History of other active malignancies within the past 5 years (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix).
4. Insufficient clinical documentation to determine the primary outcome (e.g., progression-free survival).

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07508046?

NCT07508046 is a Not Applicable OBSERVATIONAL study titled "Clinical Study on the Expression of PHGDH and Its Prognostic Value in Colorectal Cancer Patients Receiving Immunotherapy." It is currently completed and is sponsored by West China Hospital. The trial targets enrollment of 100 participants.

What conditions does NCT07508046 study?

This trial investigates treatments for Colo-rectal Cancer. The primary condition under study is Colo-rectal Cancer.

What treatments are being tested in NCT07508046?

The interventions being studied include: No intervention (OTHER). No therapeutic or experimental intervention was administered in this study. Participants were assigned to the PHGDH-high and PHGDH-low cohorts according to PHGDH expression in tumor tissues for observational analysis of clinical outcomes and treatment response.

What does Not Applicable mean for NCT07508046?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07508046?

This trial is currently "Completed." It started on 2025-11-01. The estimated completion date is 2026-01-01.

Who is sponsoring NCT07508046?

NCT07508046 is sponsored by West China Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07508046?

The trial aims to enroll 100 participants. The trial status is completed.

How is NCT07508046 designed?

This is a observational study.

What are the primary outcomes being measured in NCT07508046?

The primary outcome measures are: Objective Response Rate (ORR) (Assessed at 3 months after initiation of immunotherapy.). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07508046 being conducted?

This trial is being conducted at 1 site, including Chengdu, Sichuan (China).

Where can I find official information about NCT07508046?

The official record for NCT07508046 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07508046. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07508046 testing in simple terms?

This study looks at a gene called PHGDH and how its levels in tumors might predict how well patients with colorectal cancer respond to immunotherapy. It's for patients who have already been treated with immunotherapy for colorectal cancer.

Why is this trial significant?

This trial matters because it seeks to identify a biomarker that could help doctors choose the most effective immunotherapy for colorectal cancer patients, addressing a gap in personalized treatment.

What are the potential risks of participating in NCT07508046?

The main risk is that your stored tumor tissue may not be suitable for analysis. There are no direct risks from participation as no new treatments are given. Potential side effects are related to the immunotherapy you have already received or will receive. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07508046?

Ask your doctor if your tumor tissue is available and if you meet the study criteria. Participation involves allowing researchers to review your medical records and analyze your stored tumor tissue. There is no new treatment involved; your care will continue as planned by your doctor. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07508046 signal from an investment perspective?

This observational study provides insights into potential biomarkers for immunotherapy response in a significant cancer type, which could inform future diagnostic tool development and treatment strate This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Researchers will examine stored tumor tissue and medical records; no new treatments are given. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.