Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT03000192
Eligibility Criteria:
OVERALL ELIGIBILITY CRITERIA:
Inclusion Criteria:
* Have a new diagnosis of one of the selected cancer types determined through clinical assessment, cytology, histology or imaging or
* Have new / second primary cancer at a site previously treated for cancer
* Be awaiting primary curative intent treatment, including neoadjuvant treatment
* Be ≥16 years old.
* Be able to complete questionnaires in English
* Be able to provide written, informed consent
Exclusion Criteria:
* They do not have one of the specified cancer types
* Disease is recurrence / progression (either locally advanced or metastatic) at an existing cancer site
* They are having treatment for a potentially curative recurrence of disease e.g. locally advanced disease (i.e. they have been previously treated for the same cancer)
* They have metastatic disease from a cancer at another site (Previous diagnosis of cancer at any other site would not be grounds for exclusion unless disease was metastatic)
* They have synchronous primary cancers involving two or more of the HORIZONS specified cancer types (Please exclude synchronous gynaecological primary cancers, synchronous breast and gynaecological primary cancers, synchronous breast and non-Hodgkin's lymphoma primary cancers and synchronous non-Hodgkin's lymphoma and gynaecological cancers)
COHORT-SPECIFIC ELIGIBILITY CRITERIA:
BREAST CANCER COHORT
Inclusion:
* Women aged under 50 years old
* Stage 1, 2 or 3 breast cancer
* Have no distant metastases
* Patients due to undergo neoadjuvant treatment should be approached before this starts
For those whose core biopsy shows ductal carcinoma in situ (DCIS) only but post-excision biopsy pathology confirms invasive cancer, approach should be made as soon as possible following diagnosis and completion of the baseline questionnaire should be prior to the start of adjuvant treatment
Exclusion:
* Confirmed diagnosis of CIS (ductal or lobular) only
* Men
NON-HODGKIN LYMPHOMA COHORT
Inclusion:
* Any pathological diagnosis of Diffuse Large B Cell lymphoma (DLBCL) including;
* Secondary transforming or transformed DLBCL which has transformed from an indolent/low grade lymphoma (most commonly Follicular Lymphoma) as long as the low grade lymphoma was not treated and this is a recent transformation for which curative intent treatment has not yet started.
* Rare sub-types such as T cell rich Large B Cell Lymphoma and primary mediastinal (thymic) large B-cell lymphoma
Patients who have started steroid pre-phase treatment are eligible for approach before the start of chemotherapy.
GYNAECOLOGICAL CANCERS COHORT
ALL GYNAECOLOGICAL CANCERS
Gynaecological Cancer Exclusion criteria:
Synchronous gynaecological primary cancers. For example, synchronous ovarian and endometrial primary cancers.
OVARIAN CANCER SUB-COHORT
Ovarian Inclusion criteria:
Have a confirmed diagnosis either from cytology, histology, imaging or diagnostic primary surgery of either;
* Epithelial ovarian cancer including primary peritoneal cancer; fallopian tube cancer
* Ovarian carcinosarcoma
* Granulosa tumour of the ovary
* Patients should be entered prior to any treatment including surgery. However, where the diagnosis is only made at the time of surgery, these women may enter the study following surgery. Approach should be made as soon as possible following diagnosis and completion of the baseline questionnaire should occur prior to the start of adjuvant treatment.
* FIGO Stages: IA, IB, IC1, IC2, IC3, IIA, IIB, IIIA1
Ovarian Exclusion criteria:
* Borderline ovarian cancer
* Germ cell tumour
* Sarcoma
ENDOMETRIAL CANCER SUB-COHORT
Endometrial Inclusion criteria:
Have a confirmed diagnosis either from cytology, histology or imaging of;
* endometrial cancer
* endometrial carcinosarcoma
Patients should be entered prior to any treatment including surgery. However, where the diagnosis is only made at the time of surgery, these women may enter the study following surgery. Approach should be made as soon as possible following diagnosis and completion of the baseline questionnaire should occur prior to the start of adjuvant treatment.
\- International Federation of Gynecology and Obstetrics (FIGO) Stages: IA, IB, II, IIIA, IIIB, IIIC1, IIIC2
Endometrial Exclusion criteria
* Choriocarcinoma
* Germ cell tumour
* Sarcoma
CERVICAL CANCER SUB-COHORT
Cervical Inclusion criteria:
Have a confirmed diagnosis either from cytology, histology or imaging of;
\- Cervical cancer FIGO Stages: IA2, IB1, IB2, IIA1, IIA2, IIB, IIIA, IIIB
Cervical Exclusion criteria:
* FIGO stage IA1
* Cervical carcinoma in situ (CIS)
* Sarcoma
* Small cell cancer of the cervix
VULVAL CANCER SUB-COHORT
Vulval Inclusion criteria:
Have a confirmed diagnosis either from clinical assessment, cytology, histology, imaging of;
* Vulval cancer
* FIGO stages IA, IB, II, IIIA, IIIB, IIIC
Vulval Exclusion criteria:
* Basal cell carcinoma
* Melanoma
* Sarcoma
* Vulval intra-epithelial neoplasia (VIN)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT03000192
Study Brief:
Protocol Section:
NCT03000192