Clinical trial · Observational
YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy
A Prospective, Longitudinal Study of YKL-40 in Patients With FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer Undergoing Primary Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research trial studies chitinase 3-like 1 (cartilage glycoprotein-39) (YKL-40) in serum samples from patients with newly diagnosed stage III-IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer receiving chemotherapy. Studying samples of serum in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how well patients respond to treatment.
Conditions
Conditions (30)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Adenocarcinoma | Fallopian Tube Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Clear Cell Adenocarcinoma | Fallopian Tube Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Endometrioid Adenocarcinoma | Fallopian Tube Endometrioid Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Mucinous Adenocarcinoma | Fallopian Tube Mucinous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Serous Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Transitional Cell Carcinoma | Fallopian Tube Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (serum collection for YKL-40 and CA125)
- description
- Patients undergo collection of serum samples for analysis of YKL-40 via ELISA and CA125 via chemiluminometric sandwich immunoassay at the following time-points: at baseline; prior to beginning each course of chemotherapy (courses 1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every 6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy; and at time of disease recurrence or progression.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Laboratory Biomarker Analysis
Primary outcomes (5)
- measure
- CA125 measurements
- timeFrame
- Up to 10 years
- description
- The accuracy of each marker alone will be compared using area under the ROC curve, and assess which adds more predictive information when both are included in logistic regression.
- measure
- Objective response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a histologic diagnosis of FIGO stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who will receive primary chemotherapy for newly diagnosed disease; eligible histologic cell types include serous, mucinous, endometrioid, clear cell, transitional, mixed epithelial, undifferentiated, adenocarcinoma, not otherwise specified (NOS) and malignant Brenner tumor * Patients who have undergone full surgical staging as described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual * Patients who have met the pre-entry requirements * Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: * The following histologic cell types are not eligible: carcinosarcoma (malignant mixed Mullerian tumor) and borderline epithelial tumors (low malignant potential, atypical proliferative) * Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage IA or IB low grade lesions) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor * Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease * Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than IB; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions * With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded * Patients who receive neoadjuvant chemotherapy prior to surgical staging * Individuals with a diagnosis of rheumatoid arthritis, severe uncontrolled osteoarthritis, hepatic fibrosis or other active chronic inflammatory condition
References
Publications (0)
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